[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing GoBroad Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":552},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,42,74,101,125,147,169,190,213,230,251,271,294,311,335,354,375,398,423,440,458,473,492,512,531],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100541143","phase-1-optimised-cd33-fl-33-car-t-therapy-for-refractoryrelapsed-acute-myeloid-leukaemia-100541143",false,"NCT06326021","Optimised CD33 (FL-33) CAR T Therapy for Refractory\u002FRelapsed Acute Myeloid Leukaemia","Optimised CD33 (FL-33) CAR T Therapy for Refractory\u002FRelapsed Acute Myeloid Leukaemia：a Multi-center, Open-label, Non-randomised, Single-arm Phase Ⅰ Clinical Trial","Inclusion Criteria:\n\n* Patients who met all the inclusion criteria were eligible for enrolment.\n\n  1. Patients diagnosed with primary resistance acute myeloid leukemia, tumour surface antigen CD33 expression, chemotherapy relapse, extramedullary relapse, persistent residual positivity or relapse\u002Frefractory after allogeneic haematopoietic stem cell transplantation;\n  2. Age 1-70 years old;\n  3. No severe allergies;\n  4. Physical condition: 0-2 ECOG score;\n  5. Expected survival ≥ 60 days;\n  6. Bone marrow or cerebrospinal fluid tumour cells are positive for CD33 by flow cytometry assay or tumour tissues positive for CD33 by immunohistochemistry (CD33 determination of positivity: flow cytometry: \\>80% of tumour cells expressing CD33 and MFI similar to normal myeloid cells is considered as full positivity; tumour cells greater than 80% of expression of CD33 but MFI lower than the CD33 expression of normal myeloid cells by 1 log is considered as low expression (dim). Tumour cells with between 20-80% positive CD33 expression are partially expressed; Pathological immunohistochemistry: tumour cells\\>30% positive are considered to be positively expressed;\n  7. Self-aware patients aged 19-70 years are required to voluntarily sign an informed consent form in writing; paediatric patients aged 1-7 years can be recruited after their legal representative (guardian) had signed an informed consent form; self-aware paediatric patients aged 8-18 years voluntarily sign an informed consent form in writing, and their legal representative (guardian) are required to sign an informed consent form in writing as well;\n  8. Suitable and available allogeneic haematopoietic stem cell transplant donors are required, and allogeneic haematopoietic stem cell transplantation can be performed after receiving FL-33 CAR T treatment.\n\nExclusion Criteria:\n\n* Patients who fulfil any of the following criteria may not be enrolled.\n\n  1. Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood tumour load \\>30%; patients without history of allogeneic HSCT and peripheral blood tumour load \\>30%;\n  2. Intracranial hypertension or cerebral impaired consciousness;\n  3. Symptomatic heart failure or severe arrhythmia;\n  4. Symptoms of severe respiratory failure;\n  5. With other types of malignancy;\n  6. Diffuse intravascular coagulation;\n  7. Serum creatinine and\u002For urea nitrogen ≥ 1.5 times the normal value;\n  8. With sepsis or other uncontrollable infection;\n  9. Suffering from uncontrollable diabetes mellitus;\n  10. Severe mental disorders;\n  11. Have significant intracranial lesions on cranial MRI;\n  12. Organ transplantation (excluding haematopoietic stem cell transplantation) history;\n  13. Female patients (patients of childbearing potential) with positive blood HCG test;\n  14. Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.","ALL","1 Year","70 Years",{"count":21,"type":22},27,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is a multi-center, open-label, non-randomised, single-arm phaseⅠclinical trial to explore the safety and efficacy of FL-33 CAR T therapy for refractory\u002Frelapsed acute myeloid leukaemia. The primary endpoints are incidence and type of dose limiting toxicity within 21 days of CAR T infusion; total number, incidence and severity of adverse events (AE) 30 days after CAR T infusion. The secondary endpoints are total number, incidence and severity of AEs 30 days to 2 years after CAR T infusion; objective response rate (ORR), complete response rate (CR) and complete response with incomplete haematological recovery (CRi) by dose group at 15, 30 and 90 Days after CAR T Infusion; duration of response (DOR), progression-free survival (PFS), overall survival (OS); pharmacokinetic characteristics. The trial will use BOIN12 design to explore the optimal biological dose (OBD) of FL-33 CAR T cells for refractory\u002Frelapsed acute myeloid leukaemia. FL-33 CAR T is set at two dose levels: 5\\*10\\^5 (±20%) CAR-T cells\u002Fkg for dose 1 (DL-1) and 1\\*10\\^6 (±20%) CAR-T cells\u002Fkg for dose 2 (DL-2), and after the optimal biological dose (OBD) is determined in the dose exploration phase, the dose expansion phase will expand the trial by 6-12 cases at the OBD, enrolling up to 21-27 cases. Enrolment of more than 21 cases can be reported for analysis and the trial will be stopped when enrolment reaches 27 cases.Additionally, an independent observation group was established, comprising two sequential cohorts: a minimum of 3 subjects were enrolled starting from the lowest dose level (DL-1).",[28],"Refractory\u002FRelapsed Acute Myeloid Leukaemia","RECRUITING","2026-05-20",{"date":32,"type":33},"2026-05-22","ACTUAL",{"date":35,"type":33},"2024-04-02",{"date":37,"type":22},"2026-12-30",{"name":39,"class":40},"Beijing GoBroad Hospital","OTHER",4,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100638495","early-clinical-study-of-the-safety-tolerability-pharmacokinetics-and-effectiveness-of-str-p005-100638495","NCT07605637","Early Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Effectiveness of STR-P005","Early Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Effectiveness of STR-P005 for the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* 1\\. Voluntarily participate and sign informed consent. 2. Age 18 to 75 years (inclusive). 3. Confirmation of positive CD19 expression on peripheral blood B cells by flow cytometry.\n\n  4\\. Adequate organ function:\n  1. Hematology: Absolute neutrophil count (ANC) ≥1.0×10\\^9\\^\u002FL, absolute lymphocyte count (ALC) ≥0.1×10\\^9\\^\u002FL, hemoglobin ≥80 g\u002FL, platelet count (PLT) ≥50×10\\^9\\^\u002FL. Transfusion and growth factors cannot be used within 7 days prior to screening to meet these requirements.\n  2. Coagulation: International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN.\n  3. Liver function: Serum AST, ALT ≤3.0 × ULN, total bilirubin ≤1.5 × ULN (for participants with Gilbert's syndrome, total bilirubin \\\u003C3.0 × ULN).\n  4. Renal function: Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCl) ≥60 mL\u002Fmin (Cockcroft Gault formula); if renal involvement, CrCl ≥45 mL\u002Fmin. \\|\n  5. Cardiac function: New York Heart Association (NYHA) class I or II, left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO), and no clinically significant arrhythmia, pericardial effusion, valvular disease, or ischemic heart disease (IHD) within 8 weeks prior to screening.\n  6. Oxygen saturation: ≥92% while breathing room air at rest (by pulse oximetry); no clinically significant pleural effusion.\n\n     Exclusion Criteria:\n* Participants meeting \\*\\*ANY\\*\\* of the following exclusion criteria cannot be enrolled:\n\n  1. Previous treatment with any cellular immunotherapy, unless there is evidence that engineered immune cells have disappeared and B cells are still present in peripheral blood.\n  2. Failure to meet the following treatment washout periods:\n\n     1. Use of therapeutic doses of corticosteroids (prednisone ≥20 mg\u002Fday or equivalent) within 72 hours before first dose, though topical or inhaled steroids are allowed.\n     2. Use of mycophenolate mofetil or its derivatives, azathioprine, calcineurin inhibitors (e.g., tacrolimus, cyclosporine), mTOR inhibitors (e.g., sirolimus, everolimus), JAK inhibitors (e.g., tofacitinib, ruxolitinib, upadacitinib) within at least 2 weeks before screening.\n     3. Use of cytotoxic drugs such as cyclophosphamide, methotrexate within at least 3 weeks before screening.\n     4. Use of belimumab, B-cell targeting antibodies (e.g., anti-CD20) within at least 1 month or more; anti-cytokine antibodies within at least 2 months; natalizumab, anti-CD52, anti-CD38, ATG within at least 3 months before screening.\n     5. Other monoclonal, bispecific, trispecific antibodies, ADCs, or any B-cell depleting drugs must be washed out for 3 months or 5 half-lives (whichever is shorter) before screening.\n     6. Undergone plasmapheresis, plasma separation, hemodialysis, IVIG within 2 weeks before screening.\n  3. History of ≥ Grade 2 bleeding within 30 days before screening; or requiring long-term continuous use of anticoagulants (e.g., warfarin, low molecular weight heparin, Factor Xa inhibitors), unless INR ≤1.5 × ULN.\n  4. Severe renal disease: Severe lupus nephritis within 8 weeks before screening \\[defined as urine protein \\>6g\u002F24h or serum creatinine \\>2.5 mg\u002FdL or 221 μmol\u002FL or CrCl (Cockcroft Gault) \\\u003C30 mL\u002Fmin\\], or active nephritis requiring treatment with prohibited medications, or requiring prednisone \\>100 mg\u002Fday or equivalent corticosteroid therapy for ≥14 days.\n  5. Severe pulmonary disease within 3 months before screening, such as moderate-to-severe pulmonary arterial hypertension (mean pulmonary artery pressure \\>60 mmHg by ECHO), requiring oxygen therapy via mask or non-invasive\u002Finvasive mechanical ventilation at screening.\n  6. History of lupus crisis within 3 months before screening, such as active CNS lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe granulocytopenia, severe myocardial injury, severe lupus pneumonitis or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, etc.\n  7. History or symptoms of active non-lupus-related CNS disease within 6 months before screening (excluding isolated trigeminal nerve disease), including but not limited to: cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease, etc., as well as symptoms like epilepsy, convulsions, aphasia, dementia.\n  8. Occurrence of any of the following cardiovascular diseases within 6 months before screening (including but not limited to):\n\n     1. Congestive heart failure, myocardial infarction, unstable angina, coronary angioplasty, stent implantation, coronary\u002Fperipheral artery bypass grafting.\n     2. Severe arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, Torsade de Pointes); congenital long QT syndrome, left anterior hemiblock (bifascicular block), complete left bundle branch block or high-grade AV block; history of severe non-ischemic cardiomyopathy. Asymptomatic right bundle branch block is allowed.\n     3. Uncontrolled hypertension (systolic BP \\>160 mmHg and\u002For diastolic BP \\>100 mmHg), history of hypertensive crisis or hypertensive encephalopathy.\n     4. Current evidence of active cardiac involvement, such as pericarditis, pericardial effusion, myocarditis.\n  9. Active tuberculosis or latent tuberculosis at screening (defined as positive tuberculin skin test or interferon-gamma release assay, without clinical symptoms or radiological evidence).\n  10. Positive for HIV antibodies, or HBV-DNA, HCV-RNA, CMV-DNA exceeding assay upper limit of normal at screening.\n  11. Presence of uncontrolled fungal, bacterial, viral, or other infections deemed unsuitable for study participation by the investigator.\n  12. Presence of uncontrolled diabetes (HbA1c ≥7.0%); uncontrolled thyroid disease (TSH \\>10 mIU\u002FL or \\\u003C0.1 mIU\u002FL, and FT4 outside normal range).\n  13. History of major organ transplant (e.g., heart, lung, kidney, liver) or allogeneic hematopoietic stem cell transplant within 12 weeks or autologous stem cell transplant within 6 weeks prior to screening.\n  14. Congenital immunoglobulin deficiency.\n  15. Thrombotic thrombocytopenic purpura (TTP)\u002Fthrombotic microangiopathy (TMA).\n  16. History of other autoimmune diseases (including but not limited to eosinophilic granulomatosis with polyangiitis, cryoglobulinemic vasculitis, inclusion body myositis, anti-GBM disease, Behçet's disease, or Takayasu's arteritis) requiring systemic treatment, besides the target indication.\n  17. Family history of non-IIM conditions such as drug-induced myopathy, HIV-associated myopathy.\n  18. Previous or concurrent other active malignancies, including patients with cancer-associated polymyositis\u002Fdermatomyositis. Exceptions: cured cervical carcinoma in situ with no recurrence for at least 2 years, non-invasive basal cell or squamous cell skin cancer, radically treated localized prostate cancer, ductal carcinoma in situ of the breast post-mastectomy, and papillary thyroid cancer.\n  19. History of hypersensitivity or life-threatening reaction to the study drug or any of its components or formulation ingredients.\n  20. Pregnant or breastfeeding women.\n  21. Vaccination with any live attenuated vaccine within 6 weeks before first dose, or planned vaccination within 3 months after treatment.\n  22. Participation in other interventional clinical studies, received active investigational drug within 3 months before signing ICF, or intention to participate in another clinical trial or receive autoimmune disease treatment outside the protocol during the entire study.\n  23. Psychiatric patients with depression or suicidal tendencies.\n  24. Other factors deemed by the investigator to make the participant unsuitable for enrollment or unable to complete the study.","18 Years","75 Years",{"count":52,"type":22},18,[54],"NA","This is a single-center, single-arm, open-label, investigator-initiated early exploratory clinical trial designed to evaluate the safety and efficacy of STR-P005 in participants with relapsed\u002Frefractory autoimmune diseases.\n\nThe study will employ a traditional \"3+3\" dose-escalation design, with 3 dose groups: XXmg\u002Fkg, XXmg\u002Fkg, XXmg\u002Fkg. Dose Group 1 is the starting dose. This group includes two cohorts, A and B, to optimize the dosing frequency of STR-P005. Cohort A will receive doses Q3D (once every 3 days) on Days 1, 4, 7 (3 doses per cycle), for up to 2 cycles. Cohort B will receive doses Q4D (once every 4 days) on Days 1, 4 (2 doses per cycle), for up to 2 cycles. Based on preliminary safety, efficacy, PK\u002FPD data from Cohorts 1A and 1B, the superior regimen will be selected for escalation to Dose Groups 2 and 3. If no optimal dose is identified after escalating through the 3 dose groups, additional higher doses may be explored after SRC discussion based on all accumulated preliminary safety, efficacy, and PK\u002FPD data to further evaluate the safety and efficacy of STR-P005.",[57],"Relapsed\u002FRefractory Autoimmune Diseases",[59,60,61,62,63,64],"SLE","dcSSc","ANCA","AAV","IIM","SS","NOT_YET_RECRUITING","2026-05-18",{"date":68,"type":33},"2026-05-26",{"date":70,"type":22},"2026-06-01",{"date":72,"type":22},"2027-11-30",{"name":39,"class":40},{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100637500","a-study-to-evaluate-mtm-h-001-injection-in-adult-patients-with-b-cell-related-autoimmune-diseases-100637500","NCT07593911","A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases","An Open-Label, Single-Arm, Dose-Escalation and Expansion Basket Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Efficacy of MTM-H-001 in Patients With B-Cell-Related Autoimmune Diseases (ArchAid-002)","ArchAid-002","Inclusion Criteria:\n\n* Key inclusion criteria include：\n\n  1. Male or female, aged 18 - 75 years old (inclusive);\n  2. The participant or his\u002Fher legally acceptable representative gives consent to this clinical study participation and signs an Informed Consent Form (ICF) indicating their understanding of the objectives and procedures of the clinical study and willingness to participate in the study;\n  3. Confirmed diagnosis of the target autoimmune disease per international classification criteria;\n  4. Adequate organ function to tolerate treatment;\n  5. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and agree to use at least one effective contraceptive method throughout the study and within 6 months after the last treatment cycle.\n\nExclusion Criteria:\n\n* Key exclusion criteria include:\n\n  1. Active, severe, uncontrolled infection;\n  2. Pregnancy or breastfeeding women;\n  3. History of malignancy within the protocol-defined period, except adequately treated low-risk cancers;\n  4. Any condition that, in the investigator's opinion, would compromise safety, compliance, or interpretability of study data.",{"count":83,"type":22},75,[54],"This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with B-cell-related autoimmune diseases.",[87,88,89,90,91,92],"Systemic Lupus Erthematosus (SLE)","Lupus Nephritis (LN)","Multiple Sclerosis","Myasthenia Gravis (MG)","IgG4-Related Diseases","Rheumatoid Arthritis (RA)","2026-05-12",{"date":66,"type":33},{"date":96,"type":22},"2026-06",{"date":98,"type":22},"2031-06",{"name":39,"class":40},1,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":19,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":100},"100634374","safety-and-efficacy-of-ct0494bcp-in-participants-with-advanced-gastricesophagogastric-junction-adenocarcinoma-100634374","NCT07538856","Safety and Efficacy of CT0494BCP in Participants With Advanced Gastric\u002FEsophagogastric Junction Adenocarcinoma","A Clinical Trial Exploring the Safety and Efficacy of CT0494BCP CAR-T Cell Injection in Participants With Advanced Gastric\u002FEsophagogastric Junction Adenocarcinoma","Inclusion Criteria:\n\nVolunteer to participate in the clinical trial; I fully understand and are informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures; Age 18-70 years (inclusive), male or female; Participants with pathologically confirmed advanced gastric\u002Fesophagogastric junction adenocarcinoma; Failed at least second-line treatment (if the first-line treatment includes three drugs including taxanes \\[or anthracyclines\\], platinum and fluoropyrimidines, the participants can also be enrolled into the trial as eligible as assessed by the investigator); Participant's tumor tissue sample is CLDN18.2 positive by immunohistochemistry (IHC) staining (expression intensity ≥ 2 + and% positive tumor cells ≥ 40%); Estimated survival \\> 12 weeks; Measurable tumor lesions according to RECIST v1.1; ECOG performance status 0 \\~ 1;\n\nUnless otherwise specified, participants should meet the following criteria before clearing the lymphoma (local laboratory results that do not meet the following criteria are allowed to perform a re-examination within one week; if they still do not meet the criteria, they cannot clear the lymphoma):\n\nBlood routine: neutrophil (NE) ≥ 1.5 × 109\u002FL, lymphocyte (LY) 0.5 × 109\u002FL, platelet (PLT) ≥ 75 × 109\u002FL, hemoglobin (Hb) ≥ 9.0 g\u002FdL (no transfusion, platelet transfusion, cell growth factor \\[except recombinant erythropoietin\\] and other supportive treatment within 14 days before detection); Blood biochemistry: endogenous creatinine clearance ≥ 50 mL\u002Fmin (using Cockcroft-Gault formula), alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin ≤ 2 × ULN; Serum lipase and amylase ≤ 2 × ULN; Alkaline phosphatase ≤ 2.5 × ULN; AST, ALT and alkaline phosphatase ≤ 5 × ULN if there is bone metastasis or liver metastasis; Prothrombin time (PT) prolongation ≤ 4 s. 10. Female participants of childbearing potential must have a negative serum pregnancy test at screening and be willing to use a highly effective and reliable method of contraception for 1 year after the last dose of study treatment. The available methods are: bilateral tubal ligation\u002Fbilateral salpingectomy or bilateral tubal occlusion; Or approved oral, injected or implanted hormonal methods of birth control; Or barrier contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository; Male participants who are sexually active with a female of childbearing potential who have not had a vasectomy must agree to use a barrier method of birth control, such as a condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, or to use a contraceptive method for their partner (see Inclusion Criterion # 10). All men absolutely refrain from donating sperm for 1 year after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Pregnant or lactating females;\n2. HIV, Treponema pallidum, HCV serology positive (HCV antibody positive but HCV-RNA negative can be included), Epstein-Barr virus (EBV) DNA (plasma or whole blood) positive, cytomegalovirus (CMV) DNA positive;\n3. Any uncontrolled active infection, including but not limited to active tuberculosis, HBV infection (including HBsAg positive, or HBcAb positive with HBV DNA above the lower limit of the laboratory test in our center), and other bacterial, viral or fungal infections requiring drug treatment. Participants who use drugs to prevent infection and can continue the trial as judged by the investigator;\n4. Known HER2-positive (defined as IHC3 +, or IHC2 + with amplification by FISH);\n5. Clinically significant abnormal thyroid function as judged by the investigator (serum thyroid hormone determination includes at least FT3, FT4 and serum thyroid stimulating hormone TSH), but patients with hypothyroidism whose disease is under stable control as assessed by the investigator can enter the trial;\n6. Toxic reactions caused by previous treatment have not recovered to CTCAE v6.0 ≤ Grade 1, except for alopecia and other tolerable events as judged by the investigator or laboratory abnormalities allowed in this trial;\n7. Received anti-tumor treatment for the disease under study within 2 weeks prior to CLL, including but not limited to surgery, systemic chemotherapy (or within 5 half-lives of the drug, whichever is shorter), radiotherapy, intervention, etc., or received anti-PD-(L) 1 monoclonal antibody therapy or CLDN18.2 targeted therapy or other non-marketed clinical trial drugs within 4 weeks prior to CLL (or within 5 half-lives of the drug, whichever is shorter);\n8. Ongoing use of glucocorticoids within 7 days prior to CLL. Recent or current use of inhaled or topical dermal glucocorticoids and physiologic replacement therapy doses of glucocorticoids were not excluded;\n9. Vaccination with live attenuated vaccines within 4 weeks prior to CLL or planned during the trial;\n10. Participants with known active autoimmune disease, including but not limited to psoriasis or rheumatoid arthritis, or other conditions requiring chronic use of immunosuppressive therapy;\n11. Previous allergies to immunotherapy, tocilizumab, cyclophosphamide, fludarabine or nab-paclitaxel and other related drugs, allergies to components of CT0494BCP such as albumin, DMSO or other severe allergies;\n12. Previously received any genetic engineering modified cell therapy (including CAR-T, TCR-T cells, etc.);\n13. Presence of known or suspected central nervous system metastases;\n14. Central type or extensive lung metastasis, or extensive liver metastasis, or extensive bone metastasis;\n15. The longest diameter of a single target lesion \\> 4 cm before CLL (lymph node lesion is short axis);\n16. Participants with high risk of bleeding or perforation, such as deep and large ulcer in primary lesion, or anastomotic recurrence with full-thickness tumor invasion, or tumor lesion invasion into large vessels, as detected by CT\u002FMRI or combined with gastroscopy;\n17. Participants with current unstable or active ulcers, active gastrointestinal bleeding, or a history of major gastrointestinal bleeding within 3 months;\n18. Participants who require anticoagulation therapy such as warfarin or heparin;\n19. Participants who are receiving or anticipate the need to receive long-term antiplatelet therapy during the trial;\n20. Abdominal\u002Fpleural effusion with clinical symptoms or requiring special treatment, such as repeated drainage, abdominal\u002Fpleural drug perfusion, etc. (participants with small amount of ascites\u002Fpleural effusion that can be detected by imaging examination or controllable as assessed by the investigator can be considered for enrollment);\n21. Participants with a history of organ transplantation or who are awaiting organ transplantation;\n22. Participants who have had major surgery or significant trauma within 4 weeks prior to CLL, or anticipate the need for major surgery during the trial;\n23. Other conditions not suitable for participation in this trial as assessed by the investigator prior to CLL, including but not limited to: Poorly controlled diabetes with severe complications, poorly controlled hypertension (blood pressure \\> 160 mmHg\u002F100 mmHg), hypertension requiring vasopressor drugs or symptomatic hypotension, cardiac insufficiency (including left ventricular ejection fraction \\[LVEF\\] \\\u003C 50%), myocardial infarction within the past 6 months, arrhythmia or unstable angina poorly controlled by drug therapy, pulmonary embolism, severe chronic obstructive pulmonary disease, interstitial lung disease, clinically significant abnormal pulmonary function test, gastrointestinal obstruction or perforation within the past 3 months, severe inflammatory state (e.g. Increased neutrophils and\u002For C-reactive protein); Medical discussion with the sponsor is recommended if necessary;\n24. Inability or unwillingness of the participant to comply with the protocol requirements as assessed by the investigator;\n25. Blood oxygen saturation ≤ 95% (finger oxygen detection method is accepted, without oxygen inhalation);\n26. Participant has signs of central nervous system disease or clinically significant abnormal neurological examination results or psychiatric disorders;\n27. Patients with other incurable malignant tumors in the past 3 years or at the same time, except for cervical cancer in situ, skin basal cell carcinoma and other very low-grade tumors.",{"count":109,"type":22},50,"OBSERVATIONAL","To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric\u002Fesophagogastric junction adenocarcinoma (G\u002FGEJA) To evaluate preliminary efficacy of CT0494BCP To evaluate the cellular metabolism kinetics of CT0494BCP The investigational drug in this study is CT0494BCP cells, including CT0494 cells and CT7095 cells. Dose escalation will be performed according to the Bayesian optimal interval (BOIN) design principle (refer to the dose escalation principle in Section 4.1 Study Design Description and the flow chart of BOIN design in Figure 2 for details) and dose expansion. In the dose escalation phase, CT0494 cells were tentatively assigned to 3 escalating doses of 3.0 × 108, 4.5 × 108 and 6.0 × 108, respectively, and CT7095 cells were tentatively assigned to 2 escalating doses of 1.5 × 108 and 3.0 × 108, respectively. If the exploratory dose is not identified as a possible recommended dose (RD), a possible RD may be explored by escalating to a higher dose or tapering to a lower dose at the discretion of the investigator and sponsor in consultation. Dose groups, number of subjects per dose group, and other escalation or de-escalation decisions may be adjusted during the study based on available data.",[113,114],"Gastric","Gastric \u002F Gastroesophageal Junction Adenocarcinoma",[116],"CT0494BCP","2026-04-13",{"date":119,"type":33},"2026-04-20",{"date":121,"type":22},"2026-04",{"date":123,"type":22},"2028-03",{"name":39,"class":40},{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":100},"100632951","phase-2-a-phase-ii-clinical-study-of-shr-a1904-monotherapy-in-second-line-or-later-treatment-of-advanced-neuroendocrine-carcinoma-100632951","NCT07520357","A Phase II Clinical Study of SHR-A1904 Monotherapy in Second-Line or Later Treatment of Advanced Neuroendocrine Carcinoma","A Phase II Clinical Study of SHR-A1904 in Second-Line or Later Treatment of Advanced Neuroendocrine Carcinoma","Inclusion Criteria:\n\n1. Willing to join in this study, signed informed consent, good adherence, can cooperate with the follow-up;\n2. Age 18-75 years old, both genders;\n3. Patients with histologically confirmed advanced neuroendocrine carcinoma;\n4. Progressed form previous standard therapy (at least progressed form the first line of platinum-based chemotherapy);\n5. Tumor tissue samples (within 2 years or freshly obtained) must be available.\n6. At least one measurable lesion that met RECIST v1.1 criteria. Measurable lesions must not have received prior local therapy such as radiotherapy;\n7. ECOG Performance Status of 0-1;\n8. Must have life-expectancy of ≥ 12 weeks;\n9. Adequate function of marrow and major organs meets the following requirements：\n\n   1. Blood routine (no blood transfusion or hematopoietic stimulating factor therapy within 14 days before examination)：ANC≥1.5×109\u002FL；PLT≥100×109\u002FL；Hb≥90 g\u002FL;\n   2. Liver function (no hepatoprotective drugs within 7 days before the examination)：ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN); TBIL≤1.5 × ULN（Gilbert's syndrome subjects：TBIL≤3mg\u002FdL）;\n   3. Renal function: Cr≤1.5 × ULN or creatinine clearance ≥60 mL \u002F min (Cockcroft-Gault formula)；\n   4. Coagulation: PT≤1.5×ULN，APTT≤1.5×ULN；\n   5. Cardiac ultrasound: LVEF≥50%;\n10. Female patients of childbearing age or male patients whose partner was a female of childbearing age had to consent to use a highly effective method of contraception for the duration of the study and for 6 months after the last dose of study drug; and have no plans to have children or to donate sperm or eggs, Childbearing age female patients who were not surgically sterilized had to undergo a serum pregnancy test with a negative result within 7 days before starting study treatment.；\n\nExclusion Criteria:\n\n1. Previous receipt of claudin 18.2-targeted therapy;\n2. Previous receipt of any drug containing a topoisomerase I inhibitor drug, including antibody-drug conjugates;\n3. Merkel cell carcinoma, neuroendocrine prostate cancer, and medullary thyroid carcinoma;\n4. Untreated brain metastasis, or associated with meningeal metastasis, spinal cord compression, etc. Patients who had received previous treatment for brain metastases (radiotherapy or surgery) were eligible for enrollment if they had been stable for at least 4 weeks as confirmed by imaging and had been free of systemic hormone therapy (at a dose of \\>10 mg per day of prednisone or the equivalent) for more than 2 weeks and were asymptomatic;\n5. Spinal cord compression that could not be cured by surgery and\u002For radiotherapy;\n6. Patients with uncontrolled cancer-related pain as judged by the investigator;\n7. Patients with symptomatic pleural effusion, pericardial effusion, or ascites requiring drainage or those who had undergone therapeutic drainage of serous effusion within 2 weeks before the administration of the study drug;\n8. Patients who received anti-tumor therapy such as chemotherapy within 3 weeks before the first dose of medication, or undergo a wash-out period of 5 half-lives based on the drug's pharmacokinetics, whichever is shorter;\n9. Major organ surgery or major trauma within 4 weeks before the first dose of the study drug;\n10. Other malignant tumors occurred within 3 years before the first treatment (except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast);\n11. Patients with active interstitial lung disease, a history of interstitial lung disease or non-infectious pneumonia (any grade);\n12. Unexplained fever \\>38.5°C before randomization (fever assessed by the investigator as tumor-related may be permitted); or severe infection (CTCAE grade \\>2) within 4 weeks before the first dose, such as severe pneumonia, bacteremia, or complicated infection requiring hospitalization;\n13. Gastrointestinal perforation and\u002For fistula within 6 months prior to randomization; active gastrointestinal bleeding within 3 months prior to randomization, including but not limited to hematemesis, hematochezia, and melena, without endoscopic evidence of resolution (except for patients who underwent gastric cancer resection and whose bleeding\u002Fperforation symptoms have resolved).\n14. Arterial\u002Fvenous thrombotic events requiring intervention within 6 months before the first study dose, excluding catheter-related thrombosis.\n15. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); A history of hypertensive crisis or hypertensive encephalopathy;\n16. Refractory nausea, vomiting, chronic gastrointestinal diseases, etc.\n17. Subjects with active, known or suspected autoimmune disease (including Hiv-Positive), or a history of organ transplantation;\n18. Presence of active hepatitis B or C;\n19. A live or attenuated vaccine was administered within 4 weeks before the first dose of the study drug;\n20. The adverse reactions of antineoplastic therapy have not recovered to NCI-CTCAE v5.0 grade ≤ 1;\n21. A history of severe allergic reaction with other monoclonal antibodies or have allergic reactions to any component of SHR-A1904;\n22. According to the investigator's judgment, there are other factors that may affect the results of the study or lead to the forced termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of the subjects.",{"count":133,"type":22},23,[135],"PHASE2","This is a prospective, single-center, phase II trial designed to evaluate the efficacy and safety of SHR-A1904 monotherapy in second-line or later treatment of advanced neuroendocrine carcinoma. The primary endpoint is the objective response rate. Secondary endpoints include progression free survival, overall survival rate, duration of response, disease control Rate and adverse event.",[138],"Advanced Neuroendocrine Carcinoma","2026-04-03",{"date":141,"type":33},"2026-04-09",{"date":143,"type":22},"2026-04-30",{"date":145,"type":22},"2029-02-28",{"name":39,"class":40},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":19,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":100},"100584526","early-phase-1-clinical-study-on-the-safety-and-efficacy-of-bite-ev-in-relapsedrefractory-acute-b-cell-leukemia-100584526","NCT06890494","Clinical Study on the Safety and Efficacy of BiTE-EV in Relapsed\u002FRefractory Acute B-Cell Leukemia","Clinical Study on the Safety and Efficacy of BiTE-EV Therapy in Relapsed\u002FRefractory Acute B-Cell Lymphoblastic Leukemia","Inclusion Criteria: Patients can be enrolled in the group only if they meet all of the following conditions:\n\n* Patients with acute B lymphocytic leukemia who are clinically diagnosed as relapsed (relapsed after CAR-T treatment or relapsed after transplantation), refractory, or whose T cells cannot be used for the production of CAR-T cells.\n* Tumor cells show positive expression of CD19 detected by flow cytometry or immunohistochemistry.\n* The age is between 18 and 70 years old (inclusive).\n* The expected survival period from the date of signing the informed consent form is greater than 3 months.\n* The Eastern Cooperative Oncology Group (ECOG) performance status score is ≤ 2.\n* The functions of vital organs should meet the following requirements:\n\n  * The ejection fraction (EF) is \\> 50%, and there is no significant abnormality in the electrocardiogram.\n  * The peripheral oxygen saturation (SpO2) is ≥ 92%.\n  * The serum creatinine (Cr) is ≤ 1.5 times the upper limit of normal (ULN).\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤ 5 times the upper limit of normal (ULN), and total bilirubin (TBil) is ≤ 3 times the upper limit of normal (ULN).\n* Subjects with pregnancy plans must agree to take contraceptive measures before enrolling in the study and six months after the study. If the subject is pregnant or suspected to be pregnant, they should immediately notify the investigator.\n* The subject or the guardian understands and signs the informed consent form.\n\nExclusion Criteria:If any one of the following conditions is met, the subject cannot be enrolled in the group:\n\n* Complicated with other diseases that are not effectively controlled, including but not limited to persistent or poorly controlled infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, poorly controlled pulmonary diseases or mental disorders.\n* Having other active malignant tumors.\n* Complicated with severe infections that cannot be effectively controlled.\n* Those who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), and those with peripheral blood hepatitis B virus (HBV) DNA higher than the detection limit need to be excluded; those who are positive for hepatitis C virus (HCV) antibody and positive for peripheral blood HCV RNA need to be excluded; those with positive cytomegalovirus (CMV) DNA detection; those with positive peripheral blood Epstein-Barr virus (EBV) DNA detection.\n* Those who are positive for human immunodeficiency virus (HIV) antibody test or positive for syphilis test.\n* Having a history of severe allergy to biological products (including antibiotics).\n\nPatients with relapsed after allogeneic hematopoietic stem cell transplantation who have experienced grade 3 - 4 acute graft-versus-host disease (GvHD).\n\n* Female subjects who are pregnant or in the lactation period.\n* Active autoimmune diseases that require systemic immunosuppressive treatment.\n* Situations that the investigator believes may increase the risk of the subject or interfere with the test results.",{"count":155,"type":22},3,[157],"EARLY_PHASE1","The goal of this clinical trial is to learn if BiTE-EV works to treat relapsed\u002Frefractory acute B-cell leukemia in adults. It will also learn about the safety of BiTE-EV. The main questions it aims to answer are:\n\nCan BiTE-EV effectively treat relapsed\u002Frefractory acute B-cell lymphoblastic leukemia? What medical problems do participants have when taking BiTE-EV?\n\nParticipants will:\n\nTake BiTE-EV every other day for 1 or 2 months Keep a diary of their symptoms during the medication period During the follow-up period, visit the clinic once every 4 weeks for checkups and tests",[160],"Leukemia","2026-03-06",{"date":163,"type":33},"2026-03-10",{"date":165,"type":33},"2025-01-18",{"date":167,"type":22},"2026-12-31",{"name":39,"class":40},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":178,"briefSummary":179,"conditions":180,"keywords":183,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":189,"locationsCount":100},"100579329","phase-1-ct1190b-in-the-treatment-of-patients-with-moderate-to-severe-refractory-systemic-lupus-erythematosus-sle-or-refractoryprogressive-systemic-sclerosis-ssc-100579329","NCT06822881","CT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory\u002FProgressive Systemic Sclerosis (SSc)","A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy, in Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory\u002FProgressive Systemic Sclerosis (SSc)","Inclusion Criteria:\n\n1. Voluntary signing of the Informed Consent Form (ICF)\n2. Age range: At the time of signing the ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender.\n3. No systemic active infection within 2 weeks before screening.\n4. Contraceptive requirements for participants with child - bearing potential.\n5. Negative pregnancy test for women with child - bearing potential. Inclusion Criteria for SLE\n\n\u003C!-- -->\n\n1. Meet the EULAR\u002FACR 2019 SLE classification criteria with a disease history ≥ 6 months.\n2. Treatment and disease activity requirements:\n\n   o Before screening, the participant must have received treatment with glucocorticoids combined with immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate, cyclosporine, leflunomide) and\u002For biological agents for ≥ 3 months, with a stable dose for ≥ 2 weeks, and the disease is still in an active state. Oral corticosteroid requirements at the time of screening:\n\n   o If treated with corticosteroids alone, prednisone (or equivalent drug) ≥ 7.5 mg\u002Fday.\n\n   o When used in combination with immunosuppressive agents and\u002For biological agents, there is no minimum daily dose requirement for corticosteroids.\n3. Positive antibody test at screening: Positive antinuclear antibody, and\u002For positive anti-ds-DNA antibody, and\u002For positive anti-Smith antibody.\n4. Disease activity score or organ damage: At the screening stage, the SLEDAI - 2K score is ≥ 7 points\n5. Active organ involvement at screening: isolated skin and mucous membrane involvement is not eligible for inclusion.\n6. Adequate organ function:\n\n   o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL\u002Fmin without the need for hydration assistance.\n\n   o Bone marrow function: Defined as absolute neutrophil count (ANC) ≥ 1.0×10⁹\u002FL and hemoglobin (Hb) ≥ 60 g\u002FL. Blood transfusion and growth factors should not be used to meet these requirements within 7 days before the inclusion and exclusion screening.\n\n   o Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2× the upper limit of normal (ULN), and total bilirubin ≤ 2× the upper limit of normal (ULN).\n\n   o Coagulation function: Defined as international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN.\n\n   o Lung function: Oxygen saturation (SpO₂) ≥ 92% (measured by pulse oximeter) in room air.\n   * Cardiac function: Defined as a left ventricular ejection fraction (LVEF) ≥ 40% as evaluated by echocardiogram (ECHO) within 8 weeks before screening.\n\nInclusion Criteria for SSc\n\n1. Meet the 2013 EULAR\u002FACR classification criteria for systemic sclerosis and the diffuse - type manifestation simultaneously.\n2. Combined with interstitial pneumonia caused by SSc.\n3. Meet the definition of refractory or progressive disease:\n\n   o Refractory disease definition: Ineffective after more than 6 months of conventional treatment, or disease recurrence after remission. Conventional treatment is defined as the use of glucocorticoids (more than 1 mg\u002Fkg\u002Fd) or cyclophosphamide, and one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including Actemra, Rituxan, belimumab, tabitacicept, etc.\n   * Progressive disease definition (in the past 6 months):\n   * Skin progression: An increase in mRSS \\> 10%.\n   * Lung disease progression: A 10% decrease in FVC, or a 5% decrease in FVC accompanied by a 15% decrease in DLCO.\n4. Important organ function:\n\n   o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL\u002Fmin without the need for hydration assistance.\n\n   o Bone marrow function: Defined as absolute neutrophil count (ANC) ≥ 1.0×10⁹\u002FL and hemoglobin (Hb) ≥ 90 g\u002FL. Blood transfusion and growth factors should not be used to meet these requirements within 7 days before the inclusion and exclusion screening.\n\n   o Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2× the upper limit of normal (ULN), and total bilirubin ≤ 2× the upper limit of normal (ULN).\n\n   o Coagulation function: INR ≤ 1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN.\n\n   o Cardiac function: Good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 40%.\n\nExclusion Criteria:\n\n1. Previous history of CAR-T cell or other genetically modified T-cell therapies, or previous major organ transplantation.\n2. Use of B-cell targeted drugs (such as rituximab) within 2 months before screening.\n3. Allergy or intolerance to lymphodepletion drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to the CT1190B preparation or its excipients, or a history of other severe allergies such as anaphylactic shock.\n4. Use of corticosteroids ≥ 10 mg\u002Fday of prednisone (or equivalent drug) within 10 days before the infusion of CT1190B.\n5. Use of immunosuppressive agents that affect T-cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 10 days before the infusion of CT1190B.\n6. Use of JAK inhibitors (tofacitinib, baricitinib tablets, ruxolitinib, etc.) within 3 days before the infusion of CT1190B.\n7. Vaccination with live-attenuated vaccines, inactivated vaccines, or RNA vaccines within 1 month before screening.\n8. Diagnosis of cancer within 2 years before signing the ICF. Exceptions include non-melanoma skin cancer treated by radical therapy, local prostate cancer, biopsy-proven cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely resected breast carcinoma in situ.\n9. Undergoing major surgery within 4 weeks before signing the ICF, or planning to undergo major surgery during the study, and the investigator deems it will pose an unacceptable risk to the participant.\n10. Positive test for HIV, syphilis, active hepatitis B virus infection, or active hepatitis C virus infection at screening.\n11. History of central nervous system diseases before screening, including but not limited to cerebrovascular accident, encephalitis, epilepsy, convulsions\u002Fseizures, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, central nervous system vasculitis, cognitive impairment, organic brain syndrome, or mental illness.\n12. History of any of the following cardiovascular diseases within 1 month before screening: Heart failure of class III or IV as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other heart diseases of significant clinical significance.\n13. Participation in other clinical studies within 3 months before screening or still within five half-lives after the last dose of the drug.\n14. Current presence of any uncontrolled active infection, including but not limited to active tuberculosis, etc.\n15. History or evidence of suicidal thoughts within 6 months before signing the ICF, or any suicidal behavior within the previous 12 months, and the investigator deems there is a significant suicide risk.\n16. Pregnant or breastfeeding women.\n17. Poor compliance judged by the investigator, inability or unwillingness to comply with the requirements of the study protocol, or other reasons that make the participant unsuitable for this clinical study.\n\nExclusion Criteria for SLE\n\n1. Severe lupus nephritis within 2 months before screening, requiring hemodialysis, or receiving prednisone ≥ 100 mg\u002Fd or equivalent corticosteroid treatment for ≥ 14 days.\n2. Lupus crisis within 1 month before screening, and the investigator deems it inappropriate for the participant to participate in this study.\n3. Central nervous system manifestations caused by lupus before screening, including but not limited to lupus headache, seizures, cognitive impairment, impaired intellectual function, visual impairment, etc.\n4. History of ≥ grade 2 bleeding within 30 days before screening.\n5. Plasmapheresis, plasma separation, or hemodialysis within 14 days before screening.\n\nExclusion Criteria for SSc\n\n1\\. FVC ≤ 30% of the predicted value or DLCO (corrected for hemoglobin) ≤ 30% of the predicted value.\n\n2\\. Combined with severe kidney disease or signs of renal crisis in the participant.\n\n3\\. Risk of active tuberculosis at screening.","60 Years",{"count":21,"type":22},[25],"A Clinical Study Exploring CT1190B in the treatment of patients with moderate to severe refractory systemic lupus erythematosus (SLE) or refractory\u002Fprogressive systemic sclerosis (SSc)",[181,182],"Systemic Lupus Erythematosus (SLE)","Systemic Sclerosis (SSc)",[184],"CT1190B",{"date":163,"type":33},{"date":187,"type":33},"2025-02-20",{"date":167,"type":22},{"name":39,"class":40},{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":17,"minAge":197,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":100},"100569019","phase-1-anti-cd19-chimeric-antigen-receptor-t-cells-for-refractory-autoimmune-diseases-100569019","NCT06688799","Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases","A Single-Center, Open-Label, Non-Randomized, Single-Arm Clinical Study on the Treatment of Refractory Autoimmune Diseases With CD19-CAR T Cells","Inclusion Criteria:\n\n1\\. Systemic lupus erythematosus (SLE) 1.1. Refractory systemic lupus erythematosus (SLE) and \u002F or refractory lupus nephritis (LN)\n\n1. Male or female patients, aged 3-65 years (including 3 and 65 years);\n2. Systemic lupus erythematosus that meets the 2019 American Society of Rheumatology (ACR) \u002F European Association of Rheumatology Consortium (EULAR) classification criteria (see Annex 2);\n3. Nuclear antibody (ANA) test is clearly positive, namely ANA titer 1:80 (based on the equivalent results of Hep-2 immunofluorescence or enzyme immunoassay) and \u002F or the test at the screening visit (based on ELISA test, 30 IU \u002F mL).\n4. Refractory systemic lupus erythematosus (SLE) and \u002F or refractory lupus nephritis (LN):\n\n\u003C!-- -->\n\n1. Patients take at least 7.5 mg of prednisolone daily to maintain low disease activity or a SLEDAI 2K score (see attachment 3) of 8 or higher.\n2. Recurrence of disease activity after failure of conventional therapy or after remission. Definition of conventional treatment: using corticosteroids (1 mg \u002F kg \u002F day) and cyclophosphamide for 6 months; or any of the following immunomodulatory drugs for more than 3 months: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents such as rituximab, belimumab, and teacept.\n\n5\\) Physical strength status score (ECOG): 0-2 points; 6) The estimated survival period of 90 days; 1.2. Immune thrombocytopenia in refractory lupus (SLE-ITP)\n\n1. Age range: 18-70 years (including 18 and 70 years), gender limitation.\n2. Patients with refractory systemic lupus erythematosus (immune thrombocytopenia): meeting SLE 2019 ACR \u002F EULAR classification criteria, with at least 2 consecutive routine blood tests showing platelets lower ; no abnormal morphology of blood cells in peripheral blood smear; morphological characteristics of bone marrow cells meeting immune thrombocytopenia. Refractory systemic lupus erythematosus (immune thrombocytopenia) was defined as at least 1 course of MP shock (1g 3 days) or high-dose hormone (1mg \u002F kg d equivalent dose of glucocorticoid) combined with 1 or more immunosuppressive agents. Thrombocytopenia except for other than non-SLE causes, such as infection, myelosuppression, macropleic, hypersplenism, etc.\n3. Clinician assessment of the patients condition allowed the use of 10mg prednisone or its equivalent dose during the study and allowed the discontinuation of all immunosuppressive agents (excluding hydroxychloroquine).\n\n   1.3. refractory lupus thrombotic microangiopathy (SLE-TMA)\n\n\u003C!-- -->\n\n1. Age range: 18-70 years (including 18 and 70 years), gender limitation.\n2. Meet SLE-TMA standard; meet one of the following criteria, associated with SLE Microvascular hemolytic anemia, associated with elevated lactate dehydrogenase and peripheral blood smear fragmentation; and thrombocytopenia, except for other reasons; Renal biopsy suggested a TMA.\n\nRefractory systemic lupus erythematosus was defined as no TMA response with at least 1 course of MP shock (1g 3 days) or high-dose hormone (1mg \u002F kg d equivalent dose glucocorticoid) combined with 1 or more immunosuppressants.\n\nThe clinician assessed the patients condition allowed a glucocorticoid dose of up to 10mg prednisone or its equivalent dose during the study and allowed discontinuation of all immunosuppressive agents (excluding hydroxychloroquine).\n\n1.4.SLE Myelitis\n\n1. Age: 18-60 years old.\n2. Diagnosis: meet the diagnostic criteria for SLE.\n3. Myelitis: acute or subacute paraplegia, sensory plane, sphincter dysfunction, and tendon reflex or plantar reflex abnormalities; including but not limited to spinal cord lesions confirmed by MRI. And other causes of myelitis.\n4. Severity: lower limb muscle strength grade 3\n5. Refractory \u002F recurrent nature:\n\nRefractory: ineffective against high-dose hormone shock therapy and \u002F or combined with other immunosuppressants; Relapse: at least two recurrences in the past 12 months, or three times in the past 24 months, and one recurrence in the 12 months prior to screening.\n\n1.5.SLE Pulmonary arterial hypertension (SLE-PAH)\n\n1. Age range: 18-70 years (including 18 and 70 years), gender is unlimited.\n2. Patients with refractory connective tissue disease (pulmonary arterial hypertension):\n\n\u003C!-- -->\n\n1. confirmed as systemic lupus erythematosus according to the 1997 ACR or EULAR \u002F ACR revision standard in 2019;\n2. meeting the diagnostic criteria for PAH confirmed by a right heart catheter (as defined by 2022 ESC \u002F ERS guidelines for the treatment of pulmonary hypertension): 1) mean pulmonary artery pressure (mPAP) 20mmHg at rest; 2) pulmonary vascular wedge pressure (PAWP) 15mmHg,and pulmonary vascular resistance (PVR)\\> 2 WUs at rest;\n3. PAH did not reach risk stratification for patients in the low-risk group. Low-risk patients need to meet: 1) WHO cardiac function grades I-II; 2) 6 min walking distance (6 MWD)\\> 440 m; 3) BNP \\\u003C50 ng\u002FL, or NT-proBNP \\\u003C300 ng\u002FL; 4) right atrial pressure (RAP) \\\u003C8mmHg and heart index (CI) 2.5 L · min 1 · m 2.\n4. Subjects had received a standard dose of treatment before the first dose of study drug, including glucocorticoids (prednisone 0-30mg \u002F day, or other equivalent) for at least 4 weeks; antimalarials, single-agent immunosuppressors (allowed to apply immunosuppressors limited to: mycophenol ester or mycophenolic acid 1.5g \u002F day, azathioprine or 6-mercaptopurine 2mg \u002F kg \u002F day, methotrexate 15mg \u002F week, leflunomide 20mg \u002F day) for at least 12 weeks and not increased or replaced within 24 weeks after medication. Less than three (including prostaglandin analogues, endothelin receptor, antagonists, PDE-5 inhibitors, guanylate cyclase agonists) and have been stable for at least 4 weeks and do not increase or change within 24 weeks after drug treatment.\n5. Clinician assessment of the patients condition allowed the use of glucocorticoids not to 10mg prednisone or its equivalent dose during the study and allowed the withdrawal of all immunosuppressive agents (excluding hydroxychloroquine).\n\n1.6.SLE-Protein loss enteropathy (SLE-PLE)\n\n1. Age range: 18-70 years (including 18 and 70 years).\n2. Refractory SLE-PLE:\n\n\u003C!-- -->\n\n1. confirmed as systemic lupus erythematosus according to the 1997 ACR or EULAR \u002F ACR revision standard in 2019;\n2. Meet the SLE-PLE standard: meet one of the following standards. Clinical symptoms and laboratory findings associated with PLE, including hypoalbuminemia (urinary protein loss, severe liver disease or malnutrition, which is not completely explained by other pathological mechanisms) Refractory systemic lupus erythematosus was defined as no PLE response after at least 1 course of MP shock (1g 3 days) or high-dose hormone (1mg \u002F kg d equivalent dose of glucocorticoids) combined with 1 or more immunosuppressants.\n\nThe clinician assessed the patients condition allowed a glucocorticoid dose of up to 10mg prednisone or its equivalent dose during the study and allowed discontinuation of all immunosuppressive agents (excluding hydroxychloroquine).\n\n（3）Blood pregnancy tests were negative for women of reproductive age within 7 days before trial pretreatment; any fertile male and female patient must agree to effective contraception throughout the study and for at least 2 years. According to the researchers, a patient with fertility means a biological ability to have a living baby and a normal sexual life. Female patients without fertility (i. e., meet at least one following criteria): hysterectomy or bilateral oophorectomy, or medical confirmation of ovarian failure, or postmenopause (at least 12 consecutive months of menopause in the absence of pathological or physiological causes).\n\n2\\. Sjogrens Syndrome (SS) 2.1.SS-ITP\n\n1. The age at screening was 18 \\~ 65 years old (including 18 and 65 years old);\n2. Classification classification of primary Sjogrens Syndrome according to the 2002 International Classification or ACR \u002F EULAR in 2016, the diagnosis of primary Sjogrens syndrome for at least 6 months;\n3. Positive antinuclear antibody (titer 1:80) at screening, and \u002F or anti-SSA antibody, and \u002F or anti-SSB antibody;\n4. Active relapse \u002F refractory SS should meet at least one of the following scenarios:\n5. Relapse \u002F refractory immune thrombocytopenia: refractory to first-line therapy, platelet-inducing drugs in second-line therapy and \u002F or rituximab therapy \u002F hormone dependence or intolerance, platelet \\\u003C30109 \u002F L, and PGA\\> 1.\n\n2.2.SS Myelitis\n\n1. Age: 18-60 years old.\n2. Diagnosis: Meet the diagnostic criteria for Sjogrens syndrome (SS) (such as the American College of Rheumatology (ACR) criteria).\n3. The diagnosis of NMOSD requires neurological evaluation and MRI imaging confirmation, meeting the NMOSD diagnostic criteria as follows:\n\n   The NMOSD diagnostic criteria for AQP 4-IgG positivity; At least 1 core clinical feature; AQP 4-IgG using the best available assay.\n4. Severity: lower limb muscle strength grade 3\n5. Infractability and recurrence:\n\nRefractory: ineffective against high-dose hormone shock therapy and \u002F or combined with other immunosuppressants; Relapse: at least two recurrences in the past 12 months or three in the past 24 months and one in the 12 months prior to screening.\n\n2.3.SS-PAH\n\n1）Age range: 18-70 years (including 18 and 70 years), gender is unlimited. 2）Patients with refractory connective tissue disease (pulmonary arterial hypertension):\n\n1. Meet the 2002 AECG classification criteria or 2016 ACR \u002F EULAR classification criteria, and diagnosed as primary Sjogrens syndrome;\n2. meeting the diagnostic criteria for PAH confirmed by a right heart catheter (as defined by the 2022 ESC \u002F ERS guidelines for the treatment of pulmonary hypertension): 1) mean pulmonary artery pressure (mPAP) 20mmHg at rest; 2) pulmonary vascular wedge pressure (PAWP) 15mmHg; and pulmonary vascular resistance (PVR)\\> 2 WUs at rest;\n3. PAH did not reach risk stratification for patients in the low-risk group. Low-risk patients need to meet: 1) WHO cardiac function grades I-II; 2) 6 min walking distance (6 MWD)\\> 440 m; 3) BNP \\\u003C50 ng\u002FL, or NT-proBNP \\\u003C300 ng\u002FL; 4) right atrial pressure (RAP) \\\u003C8mmHg and heart index (CI) 2.5 L · min 1 · m 2.\n4. Subjects had received a standard dose of treatment before the first dose of study drug, including glucocorticoids (prednisone 0-30mg \u002F day, or other equivalent) for at least 4 weeks; antimalarials, single-agent immunosuppressors (allowed to apply immunosuppressors limited to: mycophenol ester or mycophenolic acid 1.5g \u002F day, azathioprine or 6-mercaptopurine 2mg \u002F kg \u002F day, methotrexate 15mg \u002F week, leflunomide 20mg \u002F day) for at least 12 weeks and not increased or replaced within 24 weeks after medication. Less than three (including prostaglandin analogues, endothelin receptor, antagonists, PDE-5 inhibitors, guanylate cyclase agonists) and have been stable for at least 4 weeks and do not increase or change within 24 weeks after drug treatment.\n5. Clinician assessment of the patients condition allowed the use of glucocorticoids not to 10mg prednisone or its equivalent dose during the study and allowed the withdrawal of all immunosuppressive agents (excluding hydroxychloroquine).\n\n3\\. Systemic sclerosis (SSc) 3.1.SSc-ILD And skin sclerosis\n\n1. the diagnosis of SSc was confirmed according to the 2013 ACR \u002F EULAR classification criteria\n2. Course of disease for 6 years after the first presentation of non-Raynaud phenomenon\n3. Age is 18 years old, 70 years old, gender is not limited in patients with ILD (1) ILD confirmed by chest HRCT, range 20%, ground glass shadow or grid shadow (2) Lung function: FVC% 60%, and DLCO 40% (3) MMF or CTX for more than 3 months (shortness of breath aggravation, or 5% decrease in FVC% or 10% decrease in DLCO%, or chest HRCT aggravation, except for infection and other factors)\n4. Skin sclerosis:\n\n(1) Patients with dcSSc (2) mRSS 12 points, or new skin involvement areas or skin progression (mRSS 3 points) were recorded in the past 6 months (3) Previous application of hormones \u002F immunosuppressants \u002F JAK inhibitors \u002F biological agents has poor efficacy 3.2.SSc-PAH\n\n1)Age range: 18-70 years (including 18 and 70 years), gender is unlimited. 2)Patients with refractory connective tissue disease (pulmonary arterial hypertension):\n\n1. Meet the 1980 ACR or ACR \u002F EULAR classification criteria in 2013 and make a diagnosis of systemic sclerosis.\n2. meeting the diagnostic criteria for PAH confirmed by a right heart catheter (as defined by the 2022 ESC \u002F ERS guidelines for the treatment of pulmonary hypertension): 1) mean pulmonary artery pressure (mPAP) 20mmHg at rest; 2) pulmonary vascular wedge pressure (PAWP) 15mmHg; 3) and pulmonary vascular resistance (PVR)\\> 2 WUs at rest;\n3. PAH did not achieve risk stratification for patients in the low-risk group. Low-risk patients need to meet: 1) WHO cardiac function grades I-II; 2) 6 min walking distance (6 MWD)\\> 440 m; 3) BNP \\\u003C50 ng\u002FL, or NT-proBNP \\\u003C300 ng\u002FL; 4) right atrial pressure (RAP) \\\u003C8mmHg and heart index (CI) 2.5 L · min 1 · m 2.\n4. Subjects had received a standard dose of stable treatment before the first dose of study drug, including glucocorticoids (prednisone 0-30mg \u002F day, or equivalent) for at least 4 weeks; antimalarials, single-agent immunosuppressive agents (limited to moxachenolate or mycophenolic acid 1.5g \u002F day, azathioprine or 6-mercaptopurine 2mg \u002F kg \u002F day, methotrexate 15mg \u002F week, leflunomide 20mg \u002F day) for at least 12 weeks and not increased or replaced within 24 weeks after treatment. Less than three (including prostaglandin analogues, endothelin receptor, antagonists, PDE-5 inhibitors, guanylate cyclase agonists) and have been stable for at least 4 weeks and do not increase or change within 24 weeks after drug treatment.\n5. Clinician assessment of the patients condition allowed the use of glucocorticoids not to 10mg prednisone or its equivalent dose during the study and allowed the withdrawal of all immunosuppressive agents (excluding hydroxychloroquine).\n\n4\\. Antiphospholipid syndrome (APS)\n\n1. Selected patients or their legal representatives shall voluntarily sign the informed consent form.\n2. Age range: 18-70 years (including 18 and 70 years), gender is unlimited.\n3. Patients with refractory APS (immune thrombocytopenia, microangiopathic APS): APS with microangiopathy and \u002F or immune thrombocytopenia (APS-ITP).\n\nPatients with refractory microangiopathic APS: according to the 2023 ACR \u002F EULAR classification criteria for APS nephropathy, myocardial lesions, alveolar hemorrhage, adrenal hemorrhage or microthrombosis, or meet the 2003 CAPS classification criteria. Refractory APS was defined as a shock to corticosteroids or high-dose hormone combined with at least one immunosuppressive agent (including CTX, tacrolimus, MMF and cyclosporin) induced remission for 3 months with continued progression or no resolution of microangiopathy.\n\nPatients with refractory APS-ITP: at least 2 consecutive routine blood tests showed platelets lower than 50109 \u002F L; microscopic morphology of blood cells in peripheral blood smear; morphological characteristics of bone marrow cells were immune thrombocytopenia. Refractory APS-ITP (immune thrombocytopenia) was defined as receiving at least 1 course of MP shock (1g 3 days) or a high dose of hormone (1mg \u002F kg d equivalent dose of glucocorticoid) combined with 1 or more immunosuppressive agents did not achieve at least partial response. Except thrombocytopenia other non-APS causes, such as infection, bone marrow suppression, macropleism and hypersplenism.\n\nThe clinician assessed the patients condition allowed a glucocorticoid dose of up to 10mg prednisone or its equivalent dose during the study and allowed discontinuation of all immunosuppressive agents (excluding hydroxychloroquine).\n\n5\\. Idiopathic inflammatory myopathy (IIM)\n\n1. Age range: 1870 years (including 18 and 70 years), gender unlimited, weight 40 kg at screening.\n2. Classification criteria: IIM patients: must meet the \"positive\" or \"very likely\" diagnosis (Lundberg et al 2017) according to the EULAR \u002F ACR adult idiopathic inflammatory myopathy (IIM) classification criteria, or by the 2010 Connors et al.\n3. Definition of refractory IIM: at least one immunosuppressive agent (e. g., azathioprine, methotrexate, mycophenolate, cyclosporine, tacrolimus, cyclohamide, leflunomide, etc.) that has received stable doses for over 2 months, When corticosteroids were reduced to 10mg daily prednisone or its equivalent dose or above, At least one of the following deterioration occurred: (i) ILD progression, The symptoms of shortness of breath worsened after the activity, Or an increased ILD score for lung HRCT, Or pulmonary function FVC% predicted decrease greater than 5%, Or DLco% decrease of\\> 10%; And (ii) deterioration of myositis, MMT-8 decreased\\> 5 points \u002F 150 points, Or creatine kinase elevated\\> 100U \u002F L.\n4. Definition of recurrent IIM: The reappearance of active IIM after 6 months of sustained disease remission causes new organ involvement or aggravation of the original involved organ, or the need for increased glucocorticoids and immunosuppressive agents.\n5. The clinician assessing the patients condition allowed the use of glucocorticoid doses not exceeding 10mg prednisone or its equivalent dose during the study period and permitted the discontinuation of all immunosuppressants.\n\n6\\. Anti-neutrophil cytoplasic antibody-associated vasculitis (AAV: GP A\u002FMPA)\n\n1. Severe patients diagnosed with GPA or MPA according to 2022 ACR \u002F EULAR criteria, treated with cyclophosphamide or hormone with rituximab (BVAS score of 0), or relapsed with maintenance therapy with rituximab or cyclophosphamide.(Recurrence is defined as the occurrence of at least one primary item, or 3 secondary items, or an abnormality of 1 or 2 secondary items in two consecutive follow-ups);\n2. The patient is positive for ANCA (anti-MPO or PR3 antibody) at present or during the course of the disease.\n\n   Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. intracranial hypertension or cerebral consciousness disorder: Intracranial pressure is kept above 15mmHg; Organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment and other brain lesions that require intervention.\n\n2\\. Symptomatic heart failure or severe arrhythmia: Left ventricular ejection fraction (LVEF) \\\u003C45% within 12 months prior to screening; Abnormal electrocardiogram (ECG): left bundle branch, double bundle branch block or other clinically significant abnormal electrocardiogram; Congenital long QT interval (QT) syndrome or Fridericia correction formula (QTcF) 470 ms; Congestive heart failure (New York Heart Association Class III or IV); 3. Severe respiratory failure or other respiratory symptoms that are difficult to control: 4. Along with other types of malignant tumors; 5. Diffuse endovascular coagulation; 6. Sepsis or other infections that are difficult to control: uncontrolled active systemic bacterial, viral, fungal or parasitic infections (except nail fungal infections) or other clinically significant active diseases; 7. Uncontrolled diabetes: fasting blood glucose (FBG)≥8.0mmol\u002FL, 2 hours postprandial blood glucose (PBG) 15 mmol\u002FL, glycated hemoglobin (HbA 1 c) after at least 3 months of diet, exercise or related treatment; combined with diabetic ketoacidosis or other uncontrollable diabetic complications; 8. Received organ transplantation (excluding bone marrow transplantation); 9. eGFR CKD-EPI \\\u003C 30 ml\u002Fmin\u002F1.73m\\^2； 10. Patients who cannot continue the immunosuppressive agents for 7 days, or repeat the disease and the investigators evaluate the risk of serious adverse reactions.","3 Years","65 Years",{"count":52,"type":22},[25,135],"The goal of this study is to evaluate the safety and effi cacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases.",[203],"Autoimmune Diseases",[205,206],"Refractory Autoimmune Diseases","CD19 CAR-T",{"date":163,"type":33},{"date":209,"type":33},"2024-11-23",{"date":211,"type":22},"2026-12",{"name":39,"class":40},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":197,"maxAge":198,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":224,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":229,"locationsCount":100},"100561081","phase-1-anti-cd19-chimeric-antigen-receptor-t-cells-for-refractory-systemic-lupus-erythematosus-100561081","NCT06585514","Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus","Open-Label, Non-Randomized, Single-Arm, Phase 1\u002F2 Study of Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Male or female, aged 3-65 years.\n2. Have a diagnosis of SLE and meet the classification criteria of 2019 European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).\n3. Positive antinuclear antibody (ANA): ANA at a titer of ≥ 1:80 on Hep-2 cells or equivalent positive test (ever) and\u002For a positive anti-dsDNA serum antibody test (based on ELISA assay, ≥ 30 IU\u002FmL).\n4. Refractory SLE and\u002For refractory lupus nephritis (LN):\n\n   • 4.1 Refractory SLE 4.1.1 Patients received at least 7.5 mg\u002Fkg\u002Fday of prednisolone to maintain low disease activity or the SLEDAI 2K score ≥8.\n\n   4.1.2 Routine treatment is ineffective or the disease relapses after remission. Definition of routine treatment: use glucocorticoid (more than 1mg\u002Fkg\u002Fd) and cyclophosphamide for 6 months; and any of the following immunomodulatory drugs for more than 3 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents such as rituximab, belizumab, or telitacicept;\n\n   • 4.2 Refractory LN 4.2.1 Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR), Biopsy-proven LN class III, IVa \\[excluding III (C), IV-S (C) and IV-G (C)\\] or, class V lupus nephritis combined with class III or IV, according to 2018 Revised International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria, see Appendix 3. Biopsy must be performed within 6 months before or during screening.\n\n   4.2.2 Refractory lupus nephritis is defined as no induced remission to treatment regimens containing at least one immunosuppressant (including glucocorticoids, CTX, tacrolimus, MME, and cyclosporine) after 3 to 6 months, accompanied by no reduction (or worsening) of proteinuria or persistent antibody positives.\n5. CD19+ on B cells and continuous withdrawal of the immunosuppressive drugs for more than 1 week.\n6. The blood routine lymphocyte count of the subjects is \\> 1 × 109\u002FL, and there is no cell collection contraindication.\n7. No severe allergy.\n8. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.\n9. Patients are expected to live for at least 90 days.\n10. Subjects and\u002For their guardian must understand and sign the informed consent.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Impaired consciousness or intracranial hypertension:\n\n   * Intracranial pressure elevation was above 15 mmHg;\n   * Organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, and other brain lesions requiring intervention.\n2. Symptomatic congestive heart failure or severe cardiac arrhythmia:\n\n   * Previously documented left ventricular ejection fraction (LVEF) by echocardiography of \\<45% in the 12 months;\n   * Abnormal electrocardiogram (ECG): left bundle branch block, bifascicular block or any clinically meaningful ECG abnormality;\n   * Congenital long QT syndrome or prolongation of the QT interval corrected for heart rate (QTcF) ≥ 470 ms. QTcF is calculated using Fridericia's Formula;\n   * Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification;\n   * Unstable or poorly controlled angina pectoris, including the prinzmetal variant of angina pectoris;\n   * Myocardial infarction within 6 months.\n3. Manifestations of severe respiratory system failure:\n\n   * Hypoxemic respiratory failure: PaO2 \\< 60 mmHg, PaCO2 \\< 50 mmHg at sea level, resting and breathing air conditions;\n   * Subjects with pulmonary hypertension (PH): mean pulmonary artery pressure (mPAP) ≥25 mmHg measured by right heart catheterization (RHC);\n   * Subjects with hypercapnia (PaCO2 ≥ 50mmHg ) and\u002For ventilatory dysfunction (PH \\<7.25 );\n   * Oxygen inhalation was required to maintain oxygen saturation;\n   * Acute or chronic respiratory diseases unrelated to SLE, such as acute pneumonia and interstitial lung disease.\n4. Co-existence with other malignancies.\n5. Disseminated intravascular coagulation (DIC).\n6. Sepsis or other uncontrollable infections: active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection) or other clinically significant active disease process.\n7. Uncontrollable diabetes: after at least 3 months of diet and exercise or similar treatment, fasting blood glucose (FBG) ≥ 8.0 mmol\u002FL, postprandial blood glucose (PBG) ≥ 15 mmol\u002FL, and glycosylated hemoglobin (HbA1c)≥8.0%; diabetic ketoacidosis or other uncontrollable complications of diabetes.\n8. Serious mental illness: alcohol or drug abuse, dementia, or any other condition that would impair the subject's ability to receive the planned treatment or to understand informed consent at the study site.\n9. Apparent and active intracranial lesions on cranial magnetic resonance imaging (MRI).\n10. Underwent organ transplantation, excepting SCT.\n11. Pregnant females or lactation.\n12. Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS) or syphilis.\n13. No peripheral blood mononuclear cells (PBMC) collection or frozen PBMC for CAR T cell manufacturing.\n14. eGFR CKD-EPI \\< 30 ml\u002Fmin\u002F1.73m2.\n15. Patients who are unable to discontinue immunosuppression agents for ≥7 days or whose condition recurs during discontinuation while the risk of serious adverse reactions is assessed by the investigator.\n16. Any active skin disease that may interfere with the evaluation of SLE, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE skin manifestations (e.g., cutaneous vasculopathies, peripapillary dilatation, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers), or drug-induced lupus.",{"count":52,"type":22},[25,135],"The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Systemic lupus erythematosus (SLE).",[181,88],[181,88,206],{"date":163,"type":33},{"date":227,"type":33},"2024-10-17",{"date":167,"type":22},{"name":39,"class":40},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":250,"locationsCount":41},"100540439","phase-1-cd5-chimeric-antigen-receptor-car-t-cells-in-subjects-with-relapsed-or-refractory-t-cell-malignancies-100540439","NCT06316856","CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-cell Malignancies","CD5 Chimeric Antigen Receptors (CAR) T Cells in Subjects With Relapsed or Refractory T-Cell Malignancies: a Multi-center, Open-label, Non-randomized, Phase 1\u002F2 Clinical Trial","Inclusion Criteria:\n\nOnly patients who meet all the following criteria can be included:\n\n1. Candidates with relapse or refractory CD5+ T-cell malignancies, who have progressed after treatment with all standard therapies or been intolerant of standard care, have limited prognosis with currently available therapies and have no available curative treatment options (such as stem-cell transplantation (SCT) or chemotherapy);\n2. For subjects who received autologous CD5 CAR T cells, the tumor burden in peripheral blood is less than 20%, and suspending anti-neoplastic treatment for more than 2 weeks;\n3. Aged 1-70 years;\n4. No severe allergy;\n5. Eastern Cooperative Oncology Group (ECOG) performance status 1 score 0 to 2;\n6. Patients are expected to live for at least 60 days;\n7. CD5+ on blasts in bone marrow (BM) or cerebrospinal fluid (CSF) and tumor tissues by flow cytometry and immunohistochemistry, respectively. (Positive rate \\>80% by flow cytometry with less than one log difference in mean fluorescence intensity from normal T cells, or positive rate \\>30% positive by immunohistochemistry);\n8. Provide a signed informed consent before any screening procedure. Subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. Children candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form and their legal guardian or patient advocate has also need to sign the treatment consent form and voluntary consent form, respectively. Children candidates of 1-7 can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form;\n9. Have available allogeneic hematopoietic stem cell transplantation donor for the subject who received newly matched donor-derived CD5 CAR T cells, and is willing to perform SCT when CR is achieved.\n\nExclusion Criteria:\n\nPatients with at least one of the following conditions are excluded:\n\n1. Impaired consciousness or intracranial hypertension;\n2. Symptomatic congestive heart failure or severe cardiac arrhythmia;\n3. Manifestations of severe respiratory system failure;\n4. Co-existence with other malignancies;\n5. Disseminated intravascular coagulation;\n6. Serum creatinine and\u002For blood urea nitrogen (BUN) ≥ 1.5-fold upper limit;\n7. Sepsis or other uncontrollable infections;\n8. Uncontrollable diabetes;\n9. Serious mental illness;\n10. Apparent and active intracranial lesions on cranial magnetic resonance imaging (MRI);\n11. Underwent organ transplantation, excepting SCT;\n12. Pregnant females;\n13. Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS) or syphilis;\n14. Post-CAR SCT is not feasible in patients who plan to receive newly matched donor-derived CD5 CAR T cells;\n15. Inability to collect peripheral blood mononuclear cells (PBMC) or no frozen PBMC available for CAR T cell manufacturing.",{"count":238,"type":22},54,[25,135],"This is a multi-center, open-label, non-randomized, phase 1\u002F2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10\\^6 (±20%) to dose level 2: 2×10\\^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10\\^5 (±20%) \u002Fkg. The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1, the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in phase 2. A total number of 54 subjects will be enrolled.",[242,243,244,245],"T-Cell Acute Lymphocytic Leukemia","Acute Lymphoblastic Leukemia, in Relapse","Refractory Acute Lymphoblastic Leukemia","T-cell Malignancies",{"date":163,"type":33},{"date":248,"type":33},"2024-06-18",{"date":37,"type":22},{"name":39,"class":40},{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":100},"100542455","clinical-trial-of-cd19-and-cd22-car-sequential-therapy-versus-single-cd19-car-bridging-to-hsct-for-rr-b-all-patients-100542455","NCT06343090","Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r\u002Fr B-ALL Patients","Pragmatic Clinical Trial of CD19 and CD22 CAR T-cell Sequential Therapy Versus Single CD19 CAR T-cell Bridging to Transplantation for Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Only patients who meet all the following criteria can be included in the group:\n\n  1. Patients who were diagnosed as primary refractory or relapsed B-ALL. (Criterion-reference: NCCN, version 2.2023); All the patients matched the diagnostic criteria of ALL according to the NCCN guideline (≥20% bone marrow lymphoblasts on hematopathology review of bone marrow aspirate and biopsy materials, which were confirmed by comprehensive flow cytometric immunophenotyping, minimal residual disease analysis and karyotyping of G-banded metaphase chromosomes). Molecular characterization could be obtained via interphase fluorescence in situ hybridization (FISH) testing, reverse transcriptase polymerase chain reaction (RT-PCR) testing, comprehensive testing by next-generation sequencing (NGS) for gene fusions and pathogenic mutations, etc. Determination of the World Health Organization ALL subtypes and cytogenetic and clinical risk groups were also allowed. B-ALL patients who did not achieve a complete remission after previous therapy (including the various treatment response scenarios shown in Table 1), who did not achieve a complete remission after at least two lines of TKI agents (including the various treatment response scenarios shown in Table 1), or who had ≥1 relapses were defined as having refractory or relapsed disease. Patients who were diagnosed as CD19- and CD22-positive high-risk B-ALL with continuous positive minimal residual disease (MRD) for more than three months after last therapy were also eligible. Patients had positive CD19 and CD22 expression on leukemia blasts by FCM (\\>80% CD19 and CD22 positive);\n  2. Age from 1 to 70 years old;\n  3. No serious allergic constitution;\n  4. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2;\n  5. Have life expectancy of at least 60 days based on investigator's judgement;\n  6. Voluntary informed consent is signed by self-aware patients aged 8-70 years and by legal representatives (guardians) of pediatric patients under 18 years of age.\n\nExclusion Criteria:\n\n* Patients with at least one of the following conditions are excluded:\n\n  1. Intracranial hypertension or unconscious;\n  2. Acute heart failure or severe arrhythmia;\n  3. Acute respiratory failure;\n  4. Other types of malignant tumors;\n  5. Diffuse intravascular coagulation;\n  6. Serum creatinine and\u002For blood urea nitrogen over 1.5 times the normal value;\n  7. Sepsis or other uncontrolled infection;\n  8. Uncontrolled diabetes mellitus;\n  9. Severe psychological disorder;\n  10. Obvious cranial lesions by cranial MRI;\n  11. More than 20 leukemic cells\u002FμL in cerebrospinal fluid;\n  12. More than 30% leukemic cells in the peripheral blood;\n  13. Organ recipients;\n  14. Pregnant or breastfeeding;\n  15. Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).",{"count":259,"type":22},353,[54],"This is a multi-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r\u002Fr B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r\u002Fr B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r\u002Fr B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled.",[263,243,264],"B-cell Acute Lymphoblastic Leukemia","Refractory Acute Lymphoid Leukemia",{"date":163,"type":33},{"date":267,"type":33},"2024-04-12",{"date":269,"type":22},"2043-09-30",{"name":39,"class":40},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":23,"phases":280,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":100},"100603984","exploratory-clinical-study-on-the-safety-of-str-p004-100603984","NCT07143617","Exploratory Clinical Study on the Safety of STR-P004","Exploratory Clinical Study on the Safety of STR-P004 in the Treatment of Patients With Relapsed or Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Fully understand the purpose, nature, method of the trial and possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form.\n2. Aged ≥18 years (including the boundary value, based on the time of signing the informed consent form), male or female;\n3. Applicable to Systemic Lupus Erythematosus (SLE):\n\n   1. Diagnosed with Systemic Lupus Erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)\u002F1997 American College of Rheumatology (ACR) classification criteria for diagnosis.\n   2. SLE-ITP: platelet count \\\u003C 50×10\\^9\u002FL in at least 2 consecutive blood routine tests; no obvious abnormalities in blood cell morphology by peripheral blood smear microscopy; bone marrow cell morphology consistent with immune thrombocytopenia; excluding thrombocytopenia caused by other non-SLE reasons, such as infection, bone marrow suppression, splenomegaly, hypersplenism, etc.; failed to achieve at least partial response after receiving at least 1 course of MP pulse therapy (1g×3 days) or high-dose hormone (1mg\u002Fkg\u002Fd equivalent glucocorticoid) combined with 1 or more immunosuppressants. Note: Complete Response (CR): platelet count ≥100×10\\^9\u002FL; Partial Response (PR): platelet count 30-100×10\\^9\u002FL, at least twice the pre-treatment level, and no bleeding.\n4. Other SLE: despite standard treatment, SLEDAI-2000 score ≥8 points and at least one BILAG Grade A or two BILAG Grade B; meeting one of the following conditions: positive antinuclear antibody (ANA) confirmed during screening, or anti-dsDNA antibody higher than normal level at screening, or anti-Sm antibody higher than normal level at screening; before the first administration of the trial drug, the subject has received at least one of the following standard treatments for 12 weeks, and the dose must be stable (dose reduction is allowed, dose increase is not allowed) for at least 30 days. Standard treatment regimens refer to stable use of any of the following: a. Antimalarial drugs combined with oral glucocorticoids (OCS, such as prednisone or equivalent dose of other hormones) and\u002For immunosuppressants (including mycophenolate mofetil, cyclophosphamide, leflunomide, methotrexate, tacrolimus, cyclosporine, azathioprine, tripterygium wilfordii); b. OCS and\u002For immunosuppressant combination therapy. If the subject is receiving OCS (such as prednisone or equivalent dose of other hormones), the following conditions must be met: the maximum dose of OCS at screening and during screening is 30 mg\u002Fday prednisone (or equivalent dose of other hormones); other drugs and traditional Chinese medicines that affect immunity can be continued at the discretion of the investigator; Applicable to Idiopathic Inflammatory Myopathies (IIM):\n\n   1. Diagnosed with possible or definite Idiopathic Inflammatory Myopathies (IIM) according to the 2017 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for diagnosis -- possible IIM: score of 5.5 points without biopsy; definite IIM: score of 6.7 points with biopsy; meeting the definition of refractory or relapsed IIM;\n   2. Definition of refractory IIM: receiving at least one immunosuppressant (such as azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, cyclophosphamide, leflunomide, etc.) at a stable dose for more than 2 months, and when glucocorticoids are reduced to 10mg prednisone per day or equivalent dose or higher, at least one of the following deteriorations occurs: (i) progression of ILD, worsening of exertional dyspnea, or increase in ILD score on lung HRCT, or decrease in FVC% predicted value of pulmonary function by more than 5%, or decrease in DLco% by \\>10%; (ii) worsening of myositis, decrease in MMT-8 by \\>5 points\u002F150 points, or increase in creatine kinase by \\>100U\u002FL compared with previous levels;\n   3. Definition of relapsed IIM: recurrence of active IIM causing new organ involvement or aggravation of originally involved organs after 6 months of continuous remission, or requiring an increase in glucocorticoids and immunosuppressants.\n\nExclusion Criteria:\n\n1. Severe lupus nephritis within 8 weeks before screening (defined as urinary protein \\>6 g\u002F24 hours or serum creatinine \\>2.5 mg\u002FdL or 221 μmol\u002FL), or need to use protocol-prohibited drugs to treat active nephritis, or need hemodialysis or receive prednisone ≥100 mg\u002Fd or equivalent glucocorticoid treatment for ≥14 days;\n2. Central nervous system diseases caused by SLE or non-SLE within 8 weeks before screening (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.);\n3. Other types of idiopathic inflammatory myopathies: inclusion body myositis, atrophic diabetes, juvenile myositis; patients with severe muscle damage or myositis with permanent weakness or cardiac involvement caused by non-IIM reasons (such as stroke);\n4. SSc-related pulmonary hypertension requiring treatment; or rapidly progressive SSc-related lower gastrointestinal tract (small and large intestine) involvement (requiring parenteral nutrition), active gastric antral vascular ectasia; previous renal crisis caused by SSc;\n5. History of important organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation;\n6. Concurrent with two or more immune diseases requiring systemic treatment, which the investigator deems unsuitable for enrollment;\n7. Suffering from IgA deficiency (serum IgA level \\\u003C10 mg\u002FdL);\n8. Participation in any other clinical trial within 4 weeks before screening or within 5 half-lives of the trial drug (whichever is longer);\n9. Previous receipt of CAR-T therapy or other cell or gene therapy;\n10. Receipt of belimumab within 2 weeks before screening; receipt of B cell-depleting drugs such as rituximab or equivalent therapy (targeting CD19, CD20, BAFF, etc.) within 1 month before screening, unless it can be proven that B cells have recovered to pre-treatment levels or within the normal range;\n11. Receipt of anti-SLE treatment other than standard treatment (such as Saphnelo) within 3 months before screening or within 5 half-lives of the drug (whichever is longer);\n12. Receipt of live\u002Fattenuated vaccine within 4 weeks before screening or planned to receive live\u002Fattenuated vaccine during the trial;\n13. Uncontrolled active infection;\n14. Admission or evidence of use of illicit drugs, drug abuse, or alcoholism;\n15. Receipt of major surgery within 4 weeks before screening or minor surgery within 2 weeks before screening; wounds must be completely healed (surgical procedures such as catheter placement are not exclusion criteria);\n16. History of any of the following cardiovascular diseases within 6 months before screening: New York Heart Association (NYHA) class III or IV heart failure, myocardial infarction, unstable angina pectoris, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other heart diseases with significant clinical significance;\n17. Any other severe underlying diseases (such as active gastric ulcer, uncontrolled epileptic seizures, cerebrovascular events, gastrointestinal bleeding, severe signs and symptoms of coagulation and coagulation dysfunction, heart disease), mental diseases, psychological, familial, or regional diseases that the investigator determines may interfere with planned staging, treatment, and follow-up, affect patient compliance, or put the patient at high risk of complications;\n18. Evidence of concurrent malignant tumors within \\\u003C5 years before screening, except for fully treated cervical carcinoma in situ, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized prostate cancer, breast ductal carcinoma in situ, or ≤T1 urothelial carcinoma. Patients with prostate cancer under active surveillance are eligible to participate in this study;\n19. Pregnant or lactating women;\n20. Viral serological test during screening: positive for human immunodeficiency virus antibody (HIV-Ab); positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBc-Ab), and HBV-DNA copy number greater than the measurable lower limit; positive for hepatitis C antibody (HCV-Ab) and HCV-RNA copy number greater than the measurable lower limit; or subjects with positive treponema pallidum antibody (TP-Ab);\n21. Subjects with active or latent tuberculosis (positive T-SPOT) detected during screening;\n22. Receipt of splenectomy for treatment within 6 months before screening;\n23. Other subjects deemed unsuitable for participation in this trial by the investigator.",{"count":279,"type":22},39,[54],"This is an open-label, multiple-dose escalation IIT clinical study aimed at evaluating the safety, tolerability, PK, and preliminary efficacy of STR-P004 in adult patients with relapsed or refractory autoimmune diseases.",[203],[284,203,285],"STR-P004","in-vivo Cart","2026-03-05",{"date":288,"type":33},"2026-03-09",{"date":290,"type":33},"2025-09-16",{"date":292,"type":22},"2026-09-14",{"name":39,"class":40},{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":310,"locationsCount":100},"100541142","phase-1-safety-tolerability-and-pharmacokinetics-of-donor-derived-cd19-car-therapy-bridged-allo-hsct-and-sequential-donor-derived-cd22-car-therapy-for-rr-b-all-a-clinical-trial-100541142","NCT06326008","Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r\u002Fr B-ALL: a Clinical Trial","Safety, Tolerability and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allogeneic Haematopoietic Stem Cell Transplantation and Sequential Donor-derived CD22 CAR Therapy in Refractory or Relapsed B Cell Acute Lymphoblastic Leukemia: a Clinical Trial","Inclusion Criteria:\n\n\\- Patients will be enrolled only if they meet all the inclusion criteria.\n\n1. Patients with relapsed or refractory CD19+\u002FCD22+ (FCM \\>95%) B-cell acute lymphoblastic leukaemia who have progressed despite or are intolerant to all standard therapies, including, but not limited to, immunotherapies such as Blinatumomab (BITE), Tyrosine kinase inhibitors (TKI), CAR T-cell therapy, etc.; Currently available therapies have a limited prognosis and there are no available curative treatment options (e.g., HSCT or chemotherapy);\n2. Peripheral blood tumour burden ≥60% or severe peripheral blood cytopenia, unsuitable\u002Funable to collect autologous lymphocytes;\n3. 1 to 18 years old;\n4. Patient's expected survival time ≥ 60 days;\n5. Physical status: ECOG score 0-2;\n6. Availability of allogeneic donors (HLA-identical or HLA-haploidentical) DSA-negative for collection of peripheral blood mononuclear cells and peripheral blood stem cells;\n7. Sign an informed consent form during the screening period. Pediatric patients under 8\\~18 years of age need to have sufficient awareness to voluntarily sign an informed consent form, and their legal representatives (guardians) also need to voluntarily sign an informed consent form; pediatric patients aged 1\\~7 years can only be recruited after their legal guardians have voluntarily signed an informed consent form.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria are not eligible for enrolment.\n\n  1. Patients who have received previous haematopoietic stem cell transplantation (including peripheral blood haematopoietic stem cell transplantation and bone marrow haematopoietic stem cell transplantation);\n  2. Intracranial hypertension or cerebral impaired consciousness;\n  3. Symptomatic heart failure or severe cardiac arrhythmia;\n  4. Symptoms of severe respiratory failure;\n  5. With other types of malignant tumours;\n  6. Diffuse intravascular coagulation;\n  7. Serum creatinine and\u002For urea nitrogen ≥ 1.5 times the normal value;\n  8. Suffering from sepsis or other uncontrollable infections;\n  9. Suffering from uncontrollable diabetes mellitus;\n  10. Severe mental disorders;\n  11. Have significant intracranial lesions on cranial MRI (excluding intracranial masses caused by central nervous system leukaemia);\n  12. Have organ transplant history;\n  13. Female patients (patients of childbearing potential) with positive blood HCG test;\n  14. Hepatitis (including Hepatitis B and Hepatitis C) and positive screening for AIDS and syphilis;\n  15. No allogeneic donor suitable for collection of peripheral blood lymphocytes and haematopoietic stem cells.",{"count":302,"type":22},48,[25],"This is an investigator-initiated, single-arm, open-label, non-randomised phase I clinical study. The objective of this trial is to evaluate the safety, tolerability and pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential donor-derived CD22 CAR Therapy for r\u002Fr B-ALL and to explore the efficacy of this therapy preliminarily. The primary endpoints are incidence and type of dose-limiting toxicity (DLT) within 28 days (i.e., 43 days after donor-derived CD19 CAR T-cell infusion) after donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell transplantation; total number, incidence and severity of adverse events from donor-derived CD19 CAR T cell infusion back to 30 days after donor-derived CD22 CAR T cell infusion (i.e., within 120 days of donor-derived CD19 CAR T cell infusion). The secondary endpoints are total number, incidence and severity of adverse events from 120 days to 2 years after donor-derived CD19 CAR T-cell infusion; ORR(CR+CRi) on days 45, 90, 120; duration of response(DOR), event-free survival(EFS), overall survival(OS); pharmacokinetics characteristics. The trial plan to enroll 3\\~12 cases in dose escalation phase and 36 cases in dose expansion phase.",[263,243],{"date":288,"type":33},{"date":308,"type":22},"2026-03-15",{"date":37,"type":22},{"name":39,"class":40},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":17,"minAge":318,"maxAge":198,"enrollmentInfo":319,"targetDuration":4,"studyType":23,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":100},"100588904","phase-1-umbilical-cord-blood-cd19-bcma-cart-cell-therapy-for-sle-ln-ssc-andpss-pah-100588904","NCT06947473","Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH.","Single Center, Open Label, Non Randomized, Single Arm Clinical Study of Cord Blood CD19-BCMA CART Cell Therapy for Refractory Lupus Nephritis (SLE-LN), Systemic Sclerosis (SSc), and Primary Sjogren's Syndrome With Pulmonary Hypertension (pSS PAH)","Inclusion Criteria:\n\n* 1\\. Refractory lupus nephritis (LN):\n\nAccording to the 2019 American College of Rheumatology (ACR) criteria and the 2018 International Society of Nephrology (ISN)\u002FSociety of Nephrology (RPS) criteria (see Appendix 3), confirmed by renal tissue biopsy as active, proliferative lupus nephritis, type III or IV \\[excluding type III (C), IV-S (C), and IV-G (C)\\], or type III\u002FIV combined with type V. Biopsy must be performed within 6 months prior to the screening visit or during the screening period.\n\n1. Male or female patients aged 3-65 years old;\n2. Systemic lupus erythematosus that meets the 2019 American College of Rheumatology (ACR)\u002FEuropean Union of Rheumatology Associations (EULAR) classification criteria (see Annex 5);\n3. The result of the anti nuclear antibody (ANA) test is clearly positive, that is, the ANA titer is ≥ 1:80 (equivalent test result based on Hep-2 immunofluorescence detection method or enzyme immunoassay method), and\u002For at the screening visit, the anti dsDNA serum antibody test is positive (≥ 30 IU\u002FmL based on ELISA detection method) according to the test results of the research center laboratory.\n4. B cell CD19+expression and discontinuation of immunosuppressive agents for more than 1 week;\n5. No severe allergic constitution;\n6. Physical condition score (ECOG) 0-2 points;\n7. Expected survival period ≥ 90 days;\n8. The subjects and\u002For their guardians are able to understand and willing to sign a written informed consent form; 2. Systemic sclerosis (SSc):\n\n\u003C!-- -->\n\n1. The selected patient or their legal representative voluntarily signs the informed consent form.\n2. Age range: 6-65 years old (including 6 and 65 years old), gender is not limited.\n3. According to the SSc classification criteria proposed by the American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) in 2013, the highest score under the same item, ≥ 9 points, can be classified as SSc (Attachment 6).\n4. Or if one sufficient condition is met, that is, the skin of both fingers thickens and extends to the proximal end of the metacarpophalangeal joint, it can be directly classified as SSc.\n\n3\\. Primary Sjogren's syndrome with pulmonary hypertension (pSS PAH):\n\n(1) The selected patients or their legal representatives voluntarily sign informed consent.\n\n(2) Age range: 18-65 years old (including 18 and 65 years old), gender is not limited.\n\n(3) Patients with refractory connective tissue disease (pulmonary arterial hypertension):\n\n1. Diagnosed with primary Sjogren's syndrome according to the 2002 AECG classification criteria or the 2016 ACR\u002FEULAR classification criteria\n2. Confirmed by right heart catheterization to meet the diagnostic criteria for PAH (as defined in the 2022 ESC\u002FERS guidelines for the diagnosis and treatment of pulmonary arterial hypertension):\n\n   * Resting mean pulmonary artery pressure (mPAP) ≥ 20mmHg;\n\n     * Pulmonary artery wedge pressure (PAWP) ≤ 15mmHg;\n\n       ③ Resting pulmonary vascular resistance (PVR)\\>2WU; (4) PAH did not reach the risk stratification of low-risk group patients. Low risk patients need to meet: ① WHO heart function classification I-II; ② 6-minute walking distance (6MWD)\\>440 meters; ③ BNP\\\u003C50ng\u002FL， Or NT proBNP\\\u003C300ng\u002FL; ④ Right atrial pressure (RAP)\\\u003C8mmHg and cardiac index (CI) ≥ 2.5 L · min-1 · m-2.\n\n       (5) Prior to the first administration of the investigational drug, a stable dose of standard treatment was received, including corticosteroids (prednisone 0-30mg\u002Fday, or equivalent other formulations) for at least 4 weeks; Antimalarial drugs and monotherapy immunosuppressants (allowed immunosuppressants are limited to: mycophenolate mofetil or mycophenolate mofetil ≤ 1.5g\u002Fday, azathioprine or 6-mercaptopurine ≤ 2mg\u002Fkg\u002Fday, methotrexate ≤ 15mg\u002Fweek, leflunomide ≤ 20mg\u002Fday) should be used for at least 12 weeks, and should not be increased or replaced within 24 weeks after drug treatment. Prior to drug treatment, use PAH targeted drugs of less than three types (including prostaglandin analogs, endothelin receptor antagonists, PDE-5 inhibitors, and guanylate cyclase agonists), which have been stable for at least 4 weeks and have not been increased or replaced within 24 weeks after drug treatment.\n\n       (6) Clinicians assess the patient's condition and allow the use of corticosteroids at a dose not exceeding 10mg prednisone or its equivalent during the study period, and allow the discontinuation of all immunosuppressants (excluding hydroxychloroquine).\n\n       (7) Women of childbearing age have a negative blood pregnancy test within 7 days prior to the pre-treatment treatment; Any male and female patient with fertility must agree to use an effective contraceptive method throughout the entire study process and for at least one year through the infusion of cell injection. The patient's fertility refers to their biological ability to give birth to live infants and have normal sexual activity. Female patients who are infertile (i.e. meet at least one of the following criteria): have undergone hysterectomy or bilateral oophorectomy, or have been medically confirmed to have ovarian failure, or have been medically confirmed to be postmenopausal (with at least 12 consecutive months of amenorrhea without pathological or physiological reasons).\n\n       (8) Having appropriate organ function, it must meet the following standards: Aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 times ULN; Total serum bilirubin ≤ 2 times ULN, unless the patient has a record of Gilbert syndrome; Bilirubin ≤ 3.0 times ULN and direct bilirubin Gilbert syndrome patients with hemoglobin ≤ 1.5 times ULN can be included; There must be a minimum level of lung reserve, with oxygen saturation greater than 95% in non oxygenated state.\n\nExclusion Criteria:\n\n* 1\\. Refractory lupus nephritis (LN):\n\n  1\\) Intracranial hypertension or cerebral consciousness disorders; 2) Symptomatic heart failure or severe arrhythmia; 3) Symptoms of severe respiratory failure; 4) Accompanied by other types of malignant tumors; 5) Diffuse intravascular coagulation; 6) Suffering from sepsis or other difficult to control infections; 7) Have uncontrollable diabetes and other endocrine diseases; 8) Serious mental disorder; 9) Head MRI examination shows obvious lesions in the skull; 10) Received organ transplantation (excluding bone marrow transplantation); 11) Female patients (those with fertility) have a positive HCG test in their blood; 12) Hepatitis (including hepatitis B and C), AIDS and syphilis screening positive persons; 13）eGFR CKD-EPI \\\u003C 30 ml\u002Fmin\u002F1.73m\\^2； 14) Any active skin disease that may interfere with the evaluation of systemic lupus erythematosus research,Including but not limited to psoriasis, dermatomyositis, systemic sclerosis, and non systemic diseases Skin manifestations of lupus erythematosus (such as skin vascular disease, pericapillary dilation)Zhang, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers)Or drug-induced lupus.\n\n  15\\) Subjects who were not successfully matched during the screening period; 16) Previously received CART treatment other than CD19-CART. 2. Primary Sjogren's syndrome with pulmonary hypertension (pSS PAH):\n\n  1\\) PH caused by other reasons: portal hypertension, hereditary hemorrhagic telangiectasia, etc; Congenital heart disease; Suspicious drugs and toxins; Chronic hypoxic disease-related pulmonary hypertension: moderate or severe obstructive pulmonary disease: FEV1\\\u003C55%； Moderate or severe restrictive lung disease: TLC\\\u003C60%； Chronic thromboembolic disease pulmonary hypertension: Pulmonary ventilation\u002Fperfusion imaging suggests moderate to high suspicion of pulmonary thromboembolism; 2) Suffering from severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents, or CNS vasculitis requiring therapeutic intervention within 60 days after baseline; 3) Dialysis patients or creatinine clearance rate less than 30mL\u002Fmin; 4) Pregnancy or breastfeeding; 5) Merge active infections (such as sepsis, bacteremia, mycosis, uncontrolled pulmonary infections, and active tuberculosis); 6) Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and\u002For hepatitis B core antibody (HBc Ab) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit; Hepatitis C (HCV) antibody positive; Positive for human immunodeficiency virus (HIV) antibodies; Individuals who test positive for syphilis antibody (TP Ab); 7) Having undergone major surgeries evaluated by researchers as unsuitable for inclusion within the previous 4 weeks prior to screening; 8) Subjects who were not successfully matched during the screening period; 9) Previously received CART treatment other than CD19-CART. 3.Systemic sclerosis (SSc)：\n\n  1\\) Overlapping connective tissue diseases; Rheumatoid arthritis, systemic lupus erythematosus, or inflammatory myopathy 2) The clinical manifestations can be explained by similar diseases of SSc, such as nephrogenic systemic fibrosis, generalized scleroplakia, eosinophilic fasciitis, diabetes scleroma, scleromyedema, erythematous acrodynia, porphyria, sclerotic lichen, graft-versus-host disease, diabetes and other endocrine diseases related hand joint diseases.\n\n  3\\) Suffering from severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents, or CNS vasculitis requiring therapeutic intervention within 60 days after baseline; 4) Dialysis patients or creatinine clearance rate less than 30mL\u002Fmin; 5) Pregnancy or breastfeeding; 6) Merge active infections (such as sepsis, bacteremia, mycosis, uncontrolled pulmonary infections, and active tuberculosis); 7) Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and\u002For hepatitis B core antibody (HBc Ab) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit; Hepatitis C (HCV) antibody positive; Positive for human immunodeficiency virus (HIV) antibodies; Individuals who test positive for syphilis antibody (TP Ab); 8) Having undergone major surgeries evaluated by researchers as unsuitable for inclusion within the previous 4 weeks prior to screening; 9) Subjects who were not successfully matched during the screening period; 10) Previously received CART treatment other than CD19-CART.","6 Years",{"count":320,"type":22},45,[25,135],"This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH receive umbilical cord blood CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of umbilical cord blood CD19BCMA CAR T cell therapy in patients with refractory lupus nephritis (SLE-LN), systemic sclerosis (SSc), and primaryjogren syndrome combined with pulmonary artery hypertension. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after theusion of umbilical cord blood CD19-BCMA CAR T cells. It is anticipated that 45-54 participants will be recruited.",[324,325,326],"Refractory Lupus Nephritis","Systemic Sclerosis","Primary Sjogren's Syndrome Combined With Pulmonary Hypertension","2026-03-01",{"date":329,"type":33},"2026-03-03",{"date":331,"type":22},"2026-03-18",{"date":333,"type":22},"2027-12-31",{"name":39,"class":40},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":17,"minAge":342,"maxAge":198,"enrollmentInfo":343,"targetDuration":4,"studyType":23,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":100},"100588903","phase-1-cd19-bcma-cart-cell-therapy-for-refractory-sle-ln-ssc-and-pss-pah-100588903","NCT06947460","CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH","CD19-BCMA CART Cell Therapy for Refractory Systemic Lupus Erythematosus Nephritis (SLE-LN), Systemic Sclerosis (SSc), and Primary Sjogren Syndrome Combined With Pulmonary Artery Hypertension (pSS-PAH): a Single-center, Open, Non-randomized, Single-arm Clinical Study","Inclusion Criteria 1. Refractory Lupus Nephritis（LN）: Patients who meet all the following requirements can be enrolled in the group.\n\nDefinition: Failure to achieve induction remission after 3 to 6 months of treatment with at least one immunosuppressive agent (including glucocorticoids, cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil, and cyclosporine), accompanied by no reduction (or worsening) in proteinuria or persistent positive autoantibodies.\n\nDiagnostic criteria : According to the 2019 American College of Rheumatology (ACR) criteria, and confirmed by renal biopsy in accordance with the 2018 International Society of Nephrology (ISN)\u002FRenal Pathology Society (RPS) criteria (Appendix 3), were diagnosed with active, proliferative lupus nephritis (LN), including Class III or IV \\[excluding Class III (C), IV-S (C), and IV-G (C)\\], or combined Class III\u002FIV with Class V.\n\n1. Male or female, aged 10-65 years;\n2. Meeting the 2019 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) Classification Criteria for Systemic Lupus Erythematosus (Appendix 4);\n3. The ANA result is positive which means ANA titer≥ 1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune assay), and\u002For according to the detection results from center laboratory, during the screening visit,the anti dsDNA serum antibody test is positive (based on ELISA assay, ≥30 IU\u002FmL);\n4. B cell CD19+ expression, and stop using immunosuppressant more than one week.\n5. The lymphocyte count in the subject's blood routine \\>0.5×109\u002FL, and no contraindications for cell collection;\n6. No serious allergic constitution;\n7. ECOG score: 0-2:\n8. Expected survival ≥90 days:\n\nSubjects and\u002For their guardian can understand and sign the informed consent form.\n\n2\\. SSc: Patients who meet all the following requirements can be enrolled in the group.\n\n1. Patients or their legal representatives sign the informed consent form;\n2. Male or female, aged 18-65 years.\n3. According to the SSc classification criteria proposed by American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR), chose the highest score under the same condition. If the score ≥9, it can be classified SSc. (Appendix 5)\n4. Satisfy a sufficient condition: the skin on the fingers of both hands is thickened and extend to the proximal end of metacarpophalangeal joint;\n5. The lymphocyte count in the subject's blood routine \\>0.5×109\u002FL, and no contraindications for cell collection.\n\n3\\. pSS-PAH: Patients who meet all the following requirements can be enrolled in the group.\n\n1. Patients or their legal representatives sign the informed consent form;\n2. Male or female, aged 18-65 years;\n3. Refractory connective tissue disease (PAH)patients:\n\n   a) Satisfy the 2002 AECG or 2016 ACR\u002F2016 EULAR classification criteria, can be diagnosed as pSS (Appendix 6); b) Confirmed by Right heart catheterization, satisfy the diagnose criteria of PAH: mPAP at rest ≥20mmHg; PAWP≤15mmHg; PVR at rest\\>2WUs.\n4. Low-risk patients whose PAH do not reach the risk stratification. The patients should meet: WHO cardiac function grading I-II; 6 minutes walking distance\\>440 m; BNP\\\u003C50ng\u002FL or NT-proBNP\\\u003C300ng\u002FL; RAP\\\u003C8mmHg and CI≥2.5 L·min-1·m-2;\n5. Subjects have received standard treatment in stable dose before first use of study drug, include: Glucocorticoids (prednisone 0-30mg\u002Fday, or other equivalent preparations) ≥4 weeks; Antimalarial drugs, single-agent immunosuppressants (MMF≤1.5g\u002Fday, AZP or 6-MP≤2mg\u002Fkg\u002Fday, MTX≤15mg\u002Fweek, Leflunomide ≤ 20mg\u002Fday) ≥12 weeks, and do not add or change in 24 weeks after drug treatment; Use PAH target drugs \\\u003C3 before drug treatment(PGAs, ETRA,PDE-5 inhibiter, GCCA), and stable at least 4 weeks, and do not add or change in 24 weeks after drug treatment;\n6. After clinician evaluate the disease condition of patients, they will allow using glucocorticoids no more than 10mg or other equivalent dose and stop all immunosuppressants (exclued hydroxychloroquine);\n7. Reproductive-aged female patients with negative blood human chorionic gonadotropin (HCG) test within 7 days before trial pre-conduct treatment; Any child-bearing male and female patients must agree to take effective contraceptive method during the process of study and within at least 1 year after cell infusion. Child-bearing patients refer that he or she has the biological ability to born alive baby and have normal sex life. Female patients without the ability of born: hysterectomy or ovariectomy, or medically confirmed ovarian failure, or medically confirmed postmenopausal (without pathological or biological reason, amenorrhea last for at least 12 months);\n8. Have appropriate organ function, the criteria are as follows:\n\n   a) AST≤3 times upper limit of normal (ULN); b) ALT ≤3 times ULN; c) T-Bil ≤2 times ULN, unless the patient has a record of Gilbert syndrome; Patients with Gilbert syndrome can be enrolled satisfied the condition of Bil≤3 times ULN and DBIl ≤1.5 times ULN; d) Must have the lowest level of lung reserve, oxygen saturation under non-oxygen inhalation state \\>95%; e) The lymphocyte count in the subject's blood routine \\>0.5×109\u002FL, and no contraindications for cell collection.\n\n4.AID Definition: Based on the reliable laboratory test, it is confirmed that one or more definite disease-related antibodies in serum are positive, laboratory results and clinical symptoms have reasonable association. Including systemic lupus erythematosus, sjogren's syndrome, systemic sclerosis, rheumatoid arthritis, connective tissue diseases, overlap syndrome, etc. At the same time exclude other etiology may cause similar symptoms and signs, infections, malignant tumors, metabolic diseases, primary organ failure, etc.\n\n1. Male or female, aged 10-65 years; Patients who do not meet the inclusive criteria of three groups above, meet any one below can be enrolled.\n2. ANA titer\\\u003C1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune assay), and\u002For during the screening visit, by the detection results from center laboratory, anti dsDNA serum antibody test is negative (based on ELISA assay, \\\u003C30 IU\u002FmL);\n3. In conventional therapy, occur recurrent infections, leading to intolerance of conventional therapy, but no active infection, serious infection(tuberculosis) currently;\n4. Patients who cannot use drugs anymore, because of bone infarction, osteonecrosis, severe bone pain caused by long term use of drugs.\n5. Patients who cannot use drugs anymore, because of vision changes, retinopathy, fundus hemorrhage caused by long term use of drugs.\n6. Patients who cannot use drugs anymore, because of endocrine-related changes (premature closure of the femoral shaft, severe obesity, diabetes, impact on growth and development, etc.) caused by long term use of drugs.\n7. Severe toxicity of blood system (≥grade3; neutrophil\\\u003C1\\*10\\^9\u002FL,platelet\\\u003C50\\*10\\^9\u002FL,hemoglobin\\\u003C80g\u002FL);\n8. Abnormal liver function (ALT ≥3 times ULN; ALT≥3 times ULN; T-Bil ≥2 times ULN);\n9. After 3 months of regular treatment, there are still have disease progression (eg. urine protein index increased by 3 times);\n10. Previously received CAR-T therapies, there are still have disease progression.\n\nExclusion criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. Refractory Lupus Nephritis (LN):\n\n1. Intracranial hypertension or disorder of consciousness;\n2. Symptomatic heart failure or severe arrhythmia;\n3. Symptoms of severe respiratory failure;\n4. Complicated with other types of malignant tumors;\n5. Diffuse intravascular coagulation;\n6. Suffering from septicemia or other uncontrollable infections;\n7. Patients with uncontrollable diabetes and other endocrine diseases;\n8. Severe mental disorders;\n9. Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI);\n10. Have received organ transplantation (excluding bone marrow transplant);\n11. Reproductive-aged female patients with positive blood human chorionic gonadotropin (HCG) test;\n12. Positive screening for hepatitis (HBV and HCV included), HIV and syphilis;\n13. The subject is unable to undergo PBMC collection, nor are there cryopreserved PBMCs available for CAR-T cell manufacturing;\n14. eGFR CKD-EPI \\\u003C 30 ml\u002Fmin\u002F1.73m\\^2;\n15. Any active skin disease that may interfere with the assessment of systemic lupus erythematosus (SLE) research, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE cutaneous manifestations (e.g., cutaneous vasculopathy, perivascular telangiectasia, sclerodactyly, rheumatoid nodules, erythema multiforme, leg ulcers), or drug-induced lupus;\n16. Previously received other CAR-T therapies except CD19-CART.\n\n2.SSc\n\n1. Other connective tissue disease: Rheumatoid Arthritis, System Lupus or Inflammatory Myopathies;\n2. Clinical manifestations can be explained by disease similar to SSc: hand joint lesions related to nephrogenic systemic fibrosis, generalized morphea, eosinophilic fasciitis, diabetic scleredema, scleromyxedema, erythromelalgia, porphyria, lichen sclerosus, graft-versus-host disease, diabetes mellitus, and other endocrine and metabolic diseases;\n3. Patients who have severe active central nervous system (CNS) lupus, including epileptic seizures, pyschosis, cerebrovascular accident or CNS vasculitis requiring treatment intervention within 60 days after baseline;\n4. Dialysis patients or Ccr \\\u003C30ml\u002Fmin;\n5. Pregnant or suckling period;\n6. Combined with active infection (eg. septicemia, bacteremia, fungemia, uncontrolled pulmonary infection, and active tuberculosis);\n7. Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab;\n8. Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening;\n9. Previously received other CAR-T therapies except CD19-CART.\n\n3.pSS-PAH\n\n1. PH caused by other reasons: Portal hypertension, hereditary hemorrhagic telangiectasia, etc.; congenital heart disease; suspected drugs and toxicants; pulmonary hypertension related to chronic hypoxic diseases: moderate or severe obstructive pulmonary disease: FEV1 \\\u003C 55%; moderate or severe restrictive pulmonary disease: TLC \\\u003C 60%; pulmonary hypertension due to chronic thromboembolic disease: pulmonary ventilation\u002Fperfusion imaging suggests moderate or high suspicion of pulmonary thromboembolism;\n2. Patients who have severe active central nervous system (CNS) lupus, including epileptic seizures, pyschosis, cerebrovascular accident or CNS vasculitis requiring treatment intervention within 60 days after baseline;\n3. Dialysis patients or Ccr \\\u003C30ml\u002Fmin;\n4. Pregnant or suckling period;\n5. Combined with active infection (eg. septicemia, bacteremia, fungemia, uncontrolled pulmonary infection, and active tuberculosis).\n6. Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab;\n7. Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening;\n8. Previously received other CAR-T therapies except CD19-CART.\n\n6\\) Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab; 7) Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening; 8) Previously received other CAR-T therapies except CD19-CART. 4. AID\n\n1. Intracranial hypertension or disorder of consciousness;\n2. Symptomatic heart failure or severe arrhythmia;\n3. Symptoms of severe respiratory failure;\n4. Complicated with other types of malignant tumors;\n5. Diffuse intravascular coagulation;\n6. Suffering from septicemia or other uncontrollable infections;\n7. Patients with uncontrollable diabetes and other endocrine diseases;\n8. Severe mental disorders;\n9. Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI);\n10. Have received organ transplantation (excluding bone marrow transplant);\n11. Reproductive-aged female patients with positive blood human chorionic gonadotropin (HCG) test;\n12. Positive screening for hepatitis (HBV and HCV included), HIV and syphilis;\n13. The subject is unable to undergo PBMC collection, nor are there cryopreserved PBMCs available for CAR-T cell manufacturing;\n14. eGFR CKD-EPI \\\u003C 30 ml\u002Fmin\u002F1.73m\\^2.","10 Years",{"count":320,"type":22},[25,135],"This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) receive CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, and pSS-PAH. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after CD19-BCMA CAR T cell infusion.",[324,325,326],"2026-02-27",{"date":329,"type":33},{"date":350,"type":33},"2025-04-18",{"date":352,"type":22},"2026-07-31",{"name":39,"class":40},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":100},"100546005","cik-cell-therapy-for-relapsed-or-refractory-acute-b-lymphoblastic-leukemia-prognostic-impact-on-patients-with-early-car-t-cell-dysfunction-100546005","NCT06389305","CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction","Cytokine-induced Killer(CIK) Cell Therapy and Its Impact on Early Functional Exhaustion of Chimeric Antigen Receptor-T(CAR-T) Cells in Relapsed or Refractory Acute B-Lymphoblastic Leukemia: A Prospective Study","Inclusion Criteria:\n\n* A patient must meet all of the following to be enrolled:\n\n  1. A confirmed diagnosis of refractory or relapsed B-ALL (criteria reference: NCCN, 2024.4), where all patients meet the National Comprehensive Cancer Network(NCCN) guidelines for the diagnosis of acute lymphoblastic leukemia (hematopathological examination of bone marrow aspirate and biopsy tissue showing ≥20% lymphoblasts in the bone marrow, confirmed by comprehensive flow cytometry (FCM) immunotyping, minimal residual disease analysis, and G-banded metaphase chromosome karyotype analysis). Molecular characteristics can be described through methods such as interphase fluorescence in situ hybridization (FISH) testing, reverse transcription polymerase chain reaction (RT-PCR) testing, and next-generation sequencing (NGS) for comprehensive detection of fusion genes and pathogenic mutations. Determination can also be made by the World Health Organization's subtypes of acute lymphoblastic leukemia, as well as cytogenetic and clinical risk groups.\n  2. Loss of CAR-T cell activity within 6 months after previous CAR-T therapy and no relapse.\n  3. Age between 1 and 39 years old.\n  4. No severe allergic constitution.\n  5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n  6. Life expectancy, as judged by the investigator, of at least 60 days.\n  7. Patients with self-awareness between 8 and 39 years of age voluntarily sign an informed consent, and the legal representative (guardians) of child patients under 18 years of age voluntarily signs an informed consent.\n\nExclusion Criteria:\n\n* A patient with at least one of the following conditions will be excluded:\n\n  1. Received bendamustine treatment within the past 9 months;\n  2. Intracranial hypertension or impaired consciousness in the brain;\n  3. Symptomatic heart failure or severe arrhythmia;\n  4. Symptoms of severe respiratory failure;\n  5. With other types of malignant tumors;\n  6. Disseminated intravascular coagulation;\n  7. Serum creatinine and\u002For blood urea nitrogen ≥ 1.5 times the normal value;\n  8. Suffering from sepsis or other uncontrollable infections;\n  9. Uncontrollable diabetes;\n  10. Severe mental disorders;\n  11. Significant lesions in the brain as detected by head magnetic resonance imaging;\n  12. Leukemic cells in the cerebrospinal fluid \\>20 cells\u002FμL;\n  13. Peripheral blood leukemic cell proportion \\>30%;\n  14. Have undergone organ transplantation;\n  15. Female patients (those with childbearing potential) are pregnant or lactating;\n  16. Active or uncontrollable infectious diseases, such as hepatitis (HBV, HCV), HIV, or syphilis.","39 Years",{"count":363,"type":22},213,[54],"This is a single-center, double-blind, randomized trial. Patients with relapsed or refractory acute B-lymphoblastic leukemia(r\u002Fr B-ALL) experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the messenger RNA(mRNA)-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r\u002Fr B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled.",[263,243,264],"2026-02-24",{"date":369,"type":33},"2026-02-25",{"date":371,"type":33},"2024-05-27",{"date":373,"type":22},"2026-05-30",{"name":39,"class":40},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":19,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":383,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":100},"100618305","phase-1-safety-tolerance-and-preliminary-efficacy-of-xh001-injection-combined-with-neoantigen-vaccine-induced-tumor-specific-t-cell-injection-in-advanced-gastrointestinal-cancer-100618305","NCT07329894","Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastrointestinal Cancer","A Single-center, Non-randomized, Open-label Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastrointestinal Cancer","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Aged between 18 and 70 years old, male or female.\n* Advanced gastrointestinal cancer that has been diagnosed by histological and\u002For cellular pathology, and which has failed to respond to second-line standard treatment or is intolerant to it, or is not suitable for standard treatment at this stage.\n* According to the RECIST 1.1 criteria for evaluating the efficacy of solid tumors, there must be at least one measurable lesion as the target lesion for efficacy evaluation. The total diameter of the overall tumor lesion (excluding bone metastases) should be ≤ 100mm, and the diameter of a single tumor lesion should be ≤ 30mm. If the lesion that has received local treatment (radiotherapy, ablation, vascular intervention, etc.) is the only lesion, then there must be clear imaging evidence of disease progression for this lesion.\n* Expected survival duration ≥ 12 weeks.\n* Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n* Requires long-term systemic administration of antiallergic drugs, or has severe hypersensitivity reactions (≥Grade 3) to XH001 injection and\u002For any of its excipients.\n* Central nervous system metastases with symptoms, and\u002For meningeal metastases.\n* Having received immunomodulatory drug therapy within 2 weeks prior to the first administration day (D1) of XH001 injection.\n* Suffer from skin diseases that may prevent the intradermal injection from reaching the target area (such as psoriasis).\n* Subjects with toxic side effects from previous treatment that have not recovered to CTCAE grade≤2, excluding hair loss.\n* Subjects who received systemic steroid treatment (daily dose exceeding 10mg of prednisone equivalent) or any other form of immunosuppressive treatment within 7 days before the first administration of XH001 injection, excluding:1) Intranasal inhalation of local steroids or local steroid injection (such as intra-articular injection); 2) Systemic corticosteroid treatment not exceeding 10mg\u002Fday of prednisone or its equivalent physiological dose.\n* Subjects who have previously received therapeutic tumor vaccines or therapeutic cell therapy products.\n* Previously received allogeneic hematopoietic stem cell or allogeneic bone marrow transplantation, or previously received solid organ transplantation, or currently using immunosuppressive drugs.\n* Have active or poorly controlled severe infections during screening period.\n* Virological tests show positive for human immunodeficiency virus antibodies, hepatitis B surface antigen and\u002For hepatitis B core antibody with hepatitis B virus DNA \\> 1000 IU\u002Fml, positive for hepatitis C virus antibodies, and positive for Treponema pallidum specific antibodies.\n* Patients with other malignancies within 5 years before enrollment, except for those with a history of appropriately treated and cured cervical carcinoma in situ, breast carcinoma in situ, or skin basal cell carcinoma.\n* Any history of autoimmune diseases.\n* Known to have active pulmonary tuberculosis (TB).\n* Patients who have received systemic chemotherapy, radiotherapy, molecular targeted therapy, biological immunotherapy, hormone therapy or unapproved clinical trial drugs\u002Finstruments within 2 weeks before screening.\n* Subjects who are still participating in other clinical trials during the screening period.\n* Pregnant or lactating women.\n* Other severe, acute, or chronic medical or psychiatric conditions, or laboratory abnormalities, that, to the investigator's discretion, may increase the risks of participating in the trial or may interfere with the interpretation of the trial results.",{"count":52,"type":22},[25],"The goal of this clinical trial is to learn the safety of tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell in treating advanced gastrointestinal cancer in adults. It will also learn if the combined treatment works to treat advanced gastrointestinal cancer.The main questions it aims to answer are:What medical problems do participants have when using the combined treatment? Does tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell eliminate or shrink the tumor, and can it prolong the patient's survival period?",[386],"Gastrointestinal Cancer",[388,386,389],"Tumor Neoantigen Vaccine","Adoptive Cell Therapy","2026-02-10",{"date":392,"type":33},"2026-02-12",{"date":394,"type":22},"2026-02",{"date":396,"type":22},"2029-10",{"name":39,"class":40},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":412,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":422},"100611579","early-phase-1-tc-g203-for-patients-with-gpc3-positive-advanced-solid-tumors-100611579","NCT07242417","TC-G203 for Patients With GPC3-Positive Advanced Solid Tumors","A Preliminary Clinical Study of TC-G203 for Patients With GPC3-Positive Recurrent\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Participants must voluntarily provide written informed consent.\n2. Aged 18-75 years (inclusive).\n3. Life expectancy ≥ 12 weeks.\n4. ECOG performance status 0-1.\n5. Failed or unsuitable for standard therapy.\n6. At least one measurable lesion per RECIST 1.1.\n7. GPC3-positive tumor confirmed by immunohistochemistry.\n8. Adequate organ and bone marrow function.\n9. Effective contraception required for participants of childbearing potential.\n10. Adequate venous access for leukapheresis.\n\nExclusion Criteria:\n\n1. Primary CNS malignancy or uncontrolled CNS metastases.\n2. Other malignancies within 5 years\n3. Active autoimmune disease or history of autoimmune disease.\n4. Immunodeficiency, including HIV positivity\n5. Bleeding disorders (inherited or acquired).\n6. Clinically significant cardiovascular disease.\n7. Active infection (including tuberculosis, hepatitis C, syphilis).\n8. Pregnant or breastfeeding women.\n9. Severe systemic or psychiatric illness.\n10. Prior cell or gene therapy.\n11. Severe drug hypersensitivity history.\n12. Investigator-assessed unsuitability for trial participation. -",{"count":406,"type":22},30,[157],"This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-G203 in patients with GPC3-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.",[410,411],"Solid Cancer","GPC3 Positive Hepatocellular Carcinoma",[410,413],"GPC3 positive hepatocellular carcinoma","2026-01-19",{"date":416,"type":33},"2026-01-21",{"date":418,"type":33},"2025-12-18",{"date":420,"type":22},"2027-11-01",{"name":39,"class":40},2,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":240,"conditions":432,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":439,"locationsCount":41},"100598348","phase-1-a-multicenter-open-label-non-randomized-single-arm-clinical-study-of-nanobody-cd5-car-t-cell-therapy-for-refractoryrelapsed-t-lymphocyte-malignancies-100598348","NCT07070323","A Multicenter, Open-Label, Non-Randomized, Single-Arm Clinical Study of Nanobody CD5-CAR T Cell Therapy for Refractory\u002FRelapsed T Lymphocyte Malignancies","nanobody CD5","Inclusion Criteria:\n\nOnly patients who meet all the following criteria can be included:\n\n1\\. Candidates with relapse or refractory CD5+ T-cell malignancies, who have progressed after treatment with all standard therapies or been intolerant of standard care, have limited prognosis with currently available therapies and have no available curative treatment options (such as stem-cell transplantation (SCT) or chemotherapy); 2. For subjects who received autologous CD5 CAR T cells, the tumor burden in peripheral blood is less than 20%, and suspending anti-neoplastic treatment for more than 2 weeks; 3. Aged 1-70 years; 4. No severe allergy; 5. Eastern Cooperative Oncology Group (ECOG) performance status 1 score 0 to 2; 6. Patients are expected to live for at least 60 days; 7. CD5+ on blasts in bone marrow (BM) or cerebrospinal fluid (CSF) and tumor tissues by flow cytometry and immunohistochemistry, respectively. (Positive rate \\>80% by flow cytometry with less than one log difference in mean fluorescence intensity from normal T cells, or positive rate \\>30% positive by immunohistochemistry); 8. Provide a signed informed consent before any screening procedure. Subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. Children candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form and their legal guardian or patient advocate has also need to sign the treatment consent form and voluntary consent form, respectively. Children candidates of 1-7 can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form; 9. Have available allogeneic hematopoietic stem cell transplantation donor for the subject who received newly matched donor-derived CD5 CAR T cells, and is willing to perform SCT when CR is achieved.\n\n\\-\n\nExclusion Criteria:\n\nPatients with at least one of the following conditions are excluded:\n\n1\\. Impaired consciousness or intracranial hypertension; 2. Symptomatic congestive heart failure or severe cardiac arrhythmia; 3. Manifestations of severe respiratory system failure; 4. Co-existence with other malignancies; 5. Disseminated intravascular coagulation; 6. Serum creatinine and\u002For blood urea nitrogen (BUN) ≥ 1.5-fold upper limit; 7. Sepsis or other uncontrollable infections; 8. Uncontrollable diabetes; 9. Serious mental illness; 10. Apparent and active intracranial lesions on cranial magnetic resonance imaging (MRI); 11. Underwent organ transplantation, excepting SCT; 12. Pregnant females; 13. Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS) or syphilis; 14. Post-CAR SCT is not feasible in patients who plan to receive newly matched donor-derived CD5 CAR T cells; 15. Inability to collect peripheral blood mononuclear cells (PBMC) or no frozen PBMC available for CAR T cell manufacturing.\n\n\\-",{"count":238,"type":22},[25,135],[242,243,244,245],"2025-11-21",{"date":435,"type":33},"2025-11-26",{"date":437,"type":33},"2025-07-09",{"date":167,"type":22},{"name":39,"class":40},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":100},"100593216","phase-1-dual-target-bcma-cd19-car-t-cell-therapy-for-rrmm-with-extramedullary-infiltration-100593216","NCT07003555","Dual-target BCMA-CD19 CAR-T Cell Therapy for RR\u002FMM With Extramedullary Infiltration","Practical Clinical Study of Dual-targeting BCMA-CD19 CAR-T Cell Therapy for Extramedullary Infiltration in Refractory\u002FRelapsed Multiple Myeloma","Inclusion Criteria:\n\n1. Voluntarily participate in the trial and have good compliance.\n2. Aged between 18 and 75 years old, regardless of gender.\n3. Diagnosed with relapsed or refractory multiple myeloma according to the criteria of the International Myeloma Working Group (IMWG)2, and have measurable extramedullary lesions due to multiple myeloma.\n4. Positive for BCMA in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue.\n5. Organ functions: ① Cardiac function: Left ventricular ejection fraction \\> 50% (by echocardiogram) in the past 2 weeks. ② Liver function: Alanine aminotransferase and aspartate aminotransferase \\\u003C 3 times the upper limit of normal (ULN). ③ Renal function: Creatinine clearance rate ≥ 40 mL\u002Fmin (by Cockcroft and Gault formula). ④ Coagulation function: PT and APPT \\\u003C 1.5 times the ULN. ⑤ Arterial oxygen saturation (SpO₂) \\> 95%. ⑥ Pulmonary function: FEV₁% predicted value ≥ 50%.\n6. Female patients of childbearing age must have a negative serum pregnancy test at screening and before receiving cyclophosphamide and fludarabine or melphalan treatment; male patients should be willing to use effective contraceptive methods for 1 year after receiving the study treatment.\n7. ECOG score ≤ 2.\n8. Expected survival time \\> 3 months.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Active infections that have not been effectively controlled.\n3. Active autoimmune diseases that have not been effectively controlled.\n4. Adverse reactions caused by previous treatments have not recovered to CTCAE grade ≤ 1.\n5. For allogeneic transplant patients, active graft - versus - host disease (GVHD) that has not been effectively controlled.\n6. Presence of any of the following: HBV - DNA copy number above the lower limit of detection; positive hepatitis C antibody (HCV - Ab) with HCV - RNA copy number above the lower limit of measurability; positive anti - Treponema pallidum antibody (TP - Ab); positive human immunodeficiency virus (HIV) antibody test.\n7. Allergic or intolerant to fludarabine or cyclophosphamide.\n8. Suffering from known symptomatic non - plasma cell infiltrative central nervous system diseases.\n9. Uncontrollable cardiovascular and cerebrovascular diseases within 6 months, such as: a. New York Heart Association (NYHA) class III or IV congestive heart failure. b. Myocardial infarction occurred or coronary artery bypass grafting (CABG) was received ≤ 6 months before enrollment. c. Clinically significant ventricular arrhythmia or a history of unexplained syncope (excluding cases caused by vasovagal or dehydration). d. A history of severe non - ischemic cardiomyopathy.\n10. A history of other untreated malignancies within the past 5 years or having other untreated malignancies concurrently.\n11. The investigator assesses that the subject cannot or is unwilling to comply with the requirements of the study protocol.\n12. Previous use of a CAR - T vector with the same structure.",{"count":52,"type":22},[25],"This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed\u002Frefractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - CD19 CAR-T cell therapy.\n\nThe primary objective is to prospectively evaluate the safety of dual-targeting BCMA and CD19 CAR - T cell therapy for extramedullary infiltration in relapsed\u002Frefractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the infusion of BCMA-CD19 CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the infusion. It is expected that no more than 18 participants will be recruited.",[451],"Relapsed or Refractory Multiple Myeloma (RRMM)",{"date":435,"type":33},{"date":454,"type":33},"2025-05-25",{"date":456,"type":22},"2027-06-25",{"name":39,"class":40},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":471,"leadSponsor":472,"locationsCount":100},"100593217","phase-1-dual-target-bcma-gprc5d-car-t-cell-therapy-for-rrmm-with-extramedullary-infiltration-100593217","NCT07003568","Dual-target BCMA-GPRC5D CAR-T Cell Therapy for RR\u002FMM With Extramedullary Infiltration","Practical Clinical Study of Dual-targeting BCMA-GPRC5D CAR-T Cell Therapy for Extramedullary Infiltration in Refractory\u002FRelapsed Multiple Myeloma","Inclusion Criteria:\n\n1. Voluntarily participate in the trial and have good compliance.\n2. Aged between 18 and 75 years old, regardless of gender.\n3. Diagnosed with relapsed or refractory multiple myeloma according to the criteria of the International Myeloma Working Group (IMWG)2, and have measurable extramedullary lesions due to multiple myeloma.\n4. Positive for BCMA and GPRC5D in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue.\n5. Organ functions: ① Cardiac function: Left ventricular ejection fraction \\> 50% (by echocardiogram) in the past 2 weeks. ② Liver function: Alanine aminotransferase and aspartate aminotransferase \\\u003C 3 times the upper limit of normal (ULN). ③ Renal function: Creatinine clearance rate ≥ 40 mL\u002Fmin (by Cockcroft and Gault formula). ④ Coagulation function: PT and APPT \\\u003C 1.5 times the ULN. ⑤ Arterial oxygen saturation (SpO₂) \\> 95%. ⑥ Pulmonary function: FEV₁% predicted value ≥ 50%.\n6. Female patients of childbearing age must have a negative serum pregnancy test at screening and before receiving cyclophosphamide and fludarabine or melphalan treatment; male patients should be willing to use effective contraceptive methods for 1 year after receiving the study treatment.\n7. ECOG score ≤ 2.\n8. Expected survival time \\> 3 months.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Active infections that have not been effectively controlled.\n3. Active autoimmune diseases that have not been effectively controlled.\n4. Adverse reactions caused by previous treatments have not recovered to CTCAE grade ≤ 1.\n5. For allogeneic transplant patients, active graft - versus - host disease (GVHD) that has not been effectively controlled.\n6. Presence of any of the following: HBV - DNA copy number above the lower limit of detection; positive hepatitis C antibody (HCV - Ab) with HCV - RNA copy number above the lower limit of measurability; positive anti - Treponema pallidum antibody (TP - Ab); positive human immunodeficiency virus (HIV) antibody test.\n7. Allergic or intolerant to fludarabine or cyclophosphamide.\n8. Suffering from known symptomatic non - plasma cell infiltrative central nervous system diseases.\n9. Uncontrollable cardiovascular and cerebrovascular diseases within 6 months, such as: a. New York Heart Association (NYHA) class III or IV congestive heart failure. b. Myocardial infarction occurred or coronary artery bypass grafting (CABG) was received ≤ 6 months before enrollment. c. Clinically significant ventricular arrhythmia or a history of unexplained syncope (excluding cases caused by vasovagal or dehydration). d. A history of severe non - ischemic cardiomyopathy.\n10. A history of other untreated malignancies within the past 5 years or having other untreated malignancies concurrently.\n11. The investigator assesses that the subject cannot or is unwilling to comply with the requirements of the study protocol.\n12. Previous use of a CAR - T vector with the same structure.",{"count":52,"type":22},[25],"This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed\u002Frefractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - GPRC5D CAR-T cell therapy.\n\nThe primary objective is to prospectively evaluate the safety of dual-targeting BCMA and GPRC5D CAR - T cell therapy for extramedullary infiltration in relapsed\u002Frefractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the reinfusion of BCMA-GPRC5D CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the reinfusion. It is expected that no more than 18 participants will be recruited.",[451],{"date":435,"type":33},{"date":454,"type":33},{"date":456,"type":22},{"name":39,"class":40},{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":486,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":41},"100540406","phase-1-autologous-and-donor-derived-cd7-car-t-therapy-in-refractory-or-relapsed-t-cell-malignancies-100540406","NCT06316427","Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Malignancies","Autologous and Donor-derived CD7 CAR T-cell Therapy in Refractory or Relapsed T-cell Malignancies: a Multi-center, Open-label, Phase Ⅰ\u002FⅡ Clinical Trial","Inclusion Criteria:\n\nOnly patients who meet all the following criteria can be included in the group:\n\n1. CD7-positive refractory or relapsed T-cell malignancies with progression or intolerance after all standard treatments, limited prognosis from currently available treatments and no available treatment options (e.g. HSCT or chemotherapy).\n2. Tumor cells in bone marrow or cerebrospinal fluid are positive for CD7 antigen by flow cytometry or tumour tissue is positive for CD7 by immunohistochemistry (CD7 antigen positivity by flow cytometry: \\>80% of tumour cells expressing CD7 with a mean fluorescence intensity \\[MFI\\] of CD7 similar to that of normal T cells are considered to have fully positive expression; \\>80% of tumor cells expressing CD7 but with an MFI of CD7 at least 1 log lower than that of normal T cells are considered to have low expression \\[dim\\]; tumor cells with a CD7 expression rate between 20-80% are considered to have partial expression; CD7 antigen positivity by pathological immunohistochemistry: \\>30%);\n3. Male or female, age 1-70 years;\n4. No severe allergic constitution;\n5. Eastern Cooperative Oncology Group (ECOG) performance status score (Oken et al., 1982) of 0-2;\n6. Life expectancy of at least 60 days as determined by the investigator;\n7. Provide a signed informed consent form prior to any screening procedures; subjects volunteering to participate in the study should be capable of understanding and signing the informed consent form and be willing to follow the study visit schedule and associated study procedures as specified in the protocol. Subjects aged 19-70 years old need to be sufficiently aware and capable of signing the informed consent form; subjects aged 1-7 years can be recruited after legal guardians or patient advocates sign the informed consent form; subjects aged 8-18 years need to be sufficiently aware and able to sign the informed consent form, and their legal guardians or patient advocates also need to sign the informed consent form.\n\nExclusion Criteria:\n\nPatients with at least one of the following conditions are excluded:\n\n1. Intracranial hypertension or unconscious;\n2. Acute heart failure or severe arrhythmia;\n3. Acute respiratory failure;\n4. Other types of malignant tumors;\n5. Diffuse intravascular coagulation;\n6. Serum creatinine and\u002For blood urea nitrogen over 1.5 times the normal value;\n7. Sepsis or other uncontrolled infection;\n8. Uncontrolled diabetes mellitus;\n9. Severe psychological disorder;\n10. Obvious cranial lesions by cranial MRI;\n11. Allergic constitution;\n12. Organ recipients;\n13. Pregnant or breastfeeding;\n14. Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).",{"count":481,"type":22},80,[25,135],"This is a multi-center, open-label, non-randomized, phase I\u002FII trial. Patients with refractory or relapsed T-cell malignancies will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r\u002Fr T-ALL\u002FT-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r\u002Fr T-ALL\u002FT-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia\u002Flymphoma (r\u002Fr T-ALL\u002FT-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled.",[485,243,244,245],"T-cell Acute Lymphoblastic Leukemia",{"date":435,"type":33},{"date":488,"type":33},"2024-03-22",{"date":490,"type":22},"2028-03-30",{"name":39,"class":40},{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":499,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":100},"100606740","to-evaluate-the-efficacy-of-ct041-in-sequential-treatment-after-first-line-treatment-of-advanced-gastricesophagogastric-junction-adenocarcinoma-100606740","NCT07179484","To Evaluate the Efficacy of CT041 in Sequential Treatment After First-line Treatment of Advanced Gastric\u002FEsophagogastric Junction Adenocarcinoma","An Open-label, Single-arm, Multicenter Phase Ib Clinical Trial Evaluating the Efficacy, Safety, and Cellular Metabolism Kinetics of CT041 Autologous CAR-T Cell Injection as a Sequential Therapy Following First-line Treatment for Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma.","Inclusion Criteria:\n\nIndividuals must meet all of the following criteria to be eligible for participation in this trial:\n\n1. Voluntarily participate in this trial; Fully understand and be informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures;\n2. Age 18-75 years (inclusive), male or female;\n3. Pathologically confirmed unresectable locally advanced or metastatic advanced gastric\u002Fesophagogastric junction (G\u002FGEJ) adenocarcinoma;\n4. Immunohistochemical (IHC) staining of tumor tissue sample is CLDN18.2 positive, defined as staining intensity ≥ 2 + in at least 40% of tumor cells;\n5. Completed 12 weeks of first-line therapy according to clinical guidance, without disease progression as assessed by the investigator:\n\n   Permitted treatment regimens include: fluoropyrimidine + platinum (± taxane) regimen chemotherapy, with or without immunotherapy or zolbetuximab. Other treatment regimens may be allowed to be included after discussion between the investigator and medical monitor of the collaborator; For the treatment regimen of every 2 weeks, 6 cycles should be completed, and for the treatment regimen of every 3 weeks, 4 cycles should be completed; According to the investigator's assessment and decision, participants without disease progression after at least 6 weeks of first-line treatment can undergo apheresis after meeting other eligibility criteria;\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (within 7 days prior to apheresis);\n7. Adequate venous access for apheresis and no other contraindications for apheresis.\n8. Laboratory test results within 7 days prior to apheresis should meet the following criteria (a repeat test within one week is allowed, if still not meeting the criteria, it will be considered a screening failure):\n\n   1. Blood routine (without transfusion, platelet transfusion, colony-stimulating factor, platelet growth factor and other supportive treatment within 7 days before test, except recombinant human erythropoietin): absolute neutrophil count (ANC) ≥ 1.5×109\u002FL, lymphocyte (LY) ≥ 0.5×109\u002FL, platelet (PLT) ≥ 75×109\u002FL, hemoglobin (Hb) ≥ 9.0 g\u002FdL. The results of blood routine test within 24 hours before apheresis should also meet the above criteria.\n   2. Blood chemistry: endogenous creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula), alanine aminotransferase (ALT) ≤ 2.5×upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5×ULN, total bilirubin ≤ 2×ULN; serum amylase ≤ 2.0×ULN; alkaline phosphatase ≤ 2.5×ULN; AST, ALT and alkaline phosphatase ≤ 5 × ULN if there is bone metastasis or liver metastasis;\n   3. Prothrombin time (PT) prolongation ≤ 4 seconds.\n9. Female participants of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and be willing to use highly effective and reliable contraception (\\\u003C 1% failure rate per year) for at least 12 months after receiving trial treatment and egg donation is absolutely prohibited during this period.\n10. Male participants who are sexually active with a female of childbearing potential, who have not had a vasectomy, must agree to practice abstinence or use highly effective and reliable contraception (failure rate \\\u003C 1% per year) for at least 12 months after receiving trial treatment and sperm donation is prohibited during this period.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded from this trial:\n\n1. Presence of a known tumor tissue with high HER2 expression;\n2. Presence of gastrointestinal bleeding\u002Fperforation\u002Fobstruction or significant risk with these, including but not limited to anastomotic recurrence involving the full thickness of gastric wall, deep large ulcer, unstable\u002Factive ulcer, history of gastrointestinal bleeding\u002Fperforation\u002Fobstruction within 3 months (excluding those with surgical resection of the lesion leading to such event);\n3. Participants who have previously received any anti-tumor therapy other than the first-line treatment regimen for G\u002FGEJ adenocarcinoma allowed in this trial (see Item 5 of the inclusion criteria), including any other systemic anti-tumor drugs, any radiotherapy or interventional therapy, etc.;\n4. Systemic anti-tumor treatment for G\u002FGEJ adenocarcinoma within 21 days (or within 5 half-lives of the drug, whichever is shorter) prior to apheresis;\n5. Major surgery (excluding cataract surgery and other surgery requiring local anesthesia) or significant traumatic injury within 4 weeks prior to apheresis and has not adequately recovered from toxicity and\u002For complications;\n6. Previously received any genetic engineering modified cell therapy (such as CAR-T cells, TCR-T cells, etc.);\n7. Toxicities from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 ≤ Grade 1, excluding alopecia, pigmentation, peripheral neuropathy, other events that, at the discretion of the investigator, do not affect the tolerability of the participant to the trial intervention, and laboratory abnormalities allowed in this trial.\n\n   Note: Participants with non-clinically significant Grade 2 AE may be allowed to be included in the trial after discussion with medical monitor of the collaborator;\n8. Positive serology for human immunodeficiency virus (HIV), Treponema pallidum, or hepatitis C virus (HCV). Participants with positive HCV antibody but negative HCV RNA can be enrolled;\n9. Any active infection, including but not limited to active tuberculosis infection, active HBV infection (including hepatitis B surface antigen \\[HBsAg\\] positive, or hepatitis B core antibody \\[HBcAb\\] positive with HBV DNA above the lower limit of the trial center lab), and infection with other pathogens requiring systemic treatment. Participants receiving prophylactic anti-infective therapy may be enrolled at the discretion of the investigator;\n10. Participants with clinically significant thyroid dysfunction or severe complications that are not suitable for participation in this trial at the discretion of the investigator. Participants with stable thyroid function after treatment can be considered for enrollment;\n11. Received systemic corticosteroids within 14 days prior to apheresis. Recent or current use of inhaled or topical skin corticosteroids and physiologic dose replacement therapy may be enrolled;\n12. Need for long-term anticoagulation\u002Fantiplatelet therapy (e.g. Warfarin, heparin, rivaroxaban, aspirin, dipyridamole, clopidogrel, etc.). Participants receiving prophylactic anticoagulation to maintain patency of venous access devices may be enrolled;\n13. Allergy to fludarabine, cyclophosphamide, nab-paclitaxel, tocilizumab and other related drugs, or known allergy to components of CT041 cell infusion preparation (such as albumin or dimethyl sulfoxide \\[DMSO\\], etc.), or history of severe allergy in the past;\n14. Presence of known or suspected central nervous system metastases;\n15. Presence of central type or extensive lung metastasis, or extensive liver metastasis, or extensive bone metastasis;\n16. Abdominal\u002Fpleural effusion with clinical symptoms or requiring special treatment, such as repeated drainage, abdominal\u002Fpleural drug perfusion, etc. (participants with small amount of ascites\u002Fpleural effusion that can be detected by imaging examination can be considered for enrollment);\n17. Participants who have previously received organ transplantation or allogeneic hematopoietic stem cell transplantation, or are awaiting organ transplantation;\n18. Vaccination with live or live attenuated vaccines within 4 weeks prior to apheresis or planned during the trial;\n19. Presence of active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, interstitial lung disease, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, multiple sclerosis, glomerulonephritis, etc.; And currently receiving or requiring long-term immunosuppressant therapy during the trial;\n20. Presence of any of the following cardiovascular diseases: uncontrolled congestive heart failure (New York Heart Association \\[NYHA\\] Class III-IV), cardiac dysfunction \\[left ventricular ejection fraction (LVEF) \\\u003C 50%\\], myocardial infarction within the last 6 months, poorly controlled arrhythmia, unstable angina, poorly controlled hypertension (blood pressure \\> 160 mmHg\u002F100 mmHg), hypotension that is symptomatic or requires vasopressor medication, and other diseases or test abnormalities that are deemed inappropriate for participation in the trial by the investigator. Discussion with medical monitor of the collaborator is recommended if necessary;\n21. Pulmonary diseases that are not suitable for participation in this trial as assessed by the investigator, including but not limited to: chronic obstructive pulmonary disease, pulmonary embolism, interstitial lung disease, clinically significant abnormal pulmonary function test, etc. Discussion with medical monitor of the collaborator is recommended if necessary;\n22. Oxygen saturation (SaO2) ≤ 95% without oxygen inhalation (finger oxygen detection method is accepted);\n23. Presence of clinically significant neurological disorders, psychiatric disorders or abnormal neurological examination results;\n24. As assessed by the investigator, the participant has poor glycemic control under adequate treatment or has experienced relevant complications;\n25. Presence of any clinicopathological features, other diseases, metabolic disorders, signs or abnormal examination results that prohibit the trial intervention, affect the interpretation of the results, preclude CT041 infusion, or are at high risk of serious complications after infusion, and are assessed as unsuitable for participation by the investigator;\n26. Uncured malignant tumor other than G\u002FGEJ cancer in the past 5 years or at the same time; Except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix and other malignancies with very low risk of metastasis or death;\n27. Pregnant or lactating females;\n28. Participants who are unable or unwilling to comply with the requirements of the clinical trial protocol as assessed by the investigator.",{"count":500,"type":22},20,"To evaluate the efficacy of CT041 in sequential treatment after first-line treatment of advanced gastric\u002Fesophagogastric junction adenocarcinoma",[503],"Gastroesophageal Junction Adenocarcinoma","2025-09-25",{"date":506,"type":33},"2025-10-01",{"date":508,"type":22},"2025-10-22",{"date":510,"type":22},"2028-09-01",{"name":39,"class":40},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":520,"conditions":521,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":4},"100608193","exploratory-study-on-the-efficacy-of-zebutinib-as-maintenance-therapy-following-car-t-cell-therapy-in-patients-with-non-hodgkin-b-cell-lymphoma-100608193","NCT07198373","Exploratory Study on the Efficacy of Zebutinib as Maintenance Therapy Following CAR-T Cell Therapy in Patients With Non-Hodgkin B-Cell Lymphoma","Inclusion Criteria:\n\n* (1) Age ≥ 18 years, no gender restrictions; (2) Expected survival time exceeding 12 weeks; (3) Cytologically or histopathologically confirmed diagnosis of non-Hodgkin B-cell lymphoma according to WHO 2016 criteria; (4) Platelet count ≥ 50 × 10⁹\u002FL; (5) Currently undergoing or scheduled to initiate oral zanubrutinib maintenance therapy following autologous or allogeneic CAR-T cell therapy; (6) Able to understand this trial and has signed an informed consent form.\n\nExclusion Criteria:\n\n* (1) Pregnant or lactating individuals; male subjects planning to conceive within one year of treatment or within one year after cell reinfusion, or whose partners plan to conceive within one year after cell reinfusion; (2) Individuals with medical conditions that affect their ability to sign a written informed consent form or comply with study procedures; or those unwilling or unable to adhere to study requirements; (3) Individuals deemed unsuitable for participation in this trial by the investigator.\n\n  1. Pregnant or lactating individuals; or male subjects planning to conceive within one year of treatment or within one year after cell infusion, or whose partners plan to conceive within one year after cell infusion; (2) Individuals with medical conditions that prevent signing a written informed consent form or complying with study procedures; or those unwilling or unable to comply with study requirements; (3) Individuals deemed unsuitable for this trial by the investigator.",{"count":519,"type":22},40,"This study is a single-center, Phase IV clinical trial designed to collect and analyze data on the efficacy and safety of zanubrutinib as maintenance therapy following CAR-T cell therapy in subjects with non-Hodgkin B-cell lymphoma.",[522],"B Cell Lymphoma","2025-09-21",{"date":525,"type":33},"2025-09-30",{"date":527,"type":22},"2025-09-20",{"date":529,"type":22},"2028-12-30",{"name":39,"class":40},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":198,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":540,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":100},"100605824","phase-1-a-study-of-ol-cd19-gdt-in-relapsed-refractory-autoimmune-diseases-100605824","NCT07167537","A Study of OL-CD19-GDT in Relapsed\u002F Refractory Autoimmune Diseases","An Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Allogeneic CAR-T Cell Therapy (OL-CD19-GDT) in the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Adults aged 18-65 years old\n* ECOG 0-2\n* Adequate organ function\n* Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and must agree to use a highly effective contraceptive method starting from the time of lymphodepletion and for 2 years after dosing of the IMP\n* SSc specific:\n\n  a)Fulfilling the 2013 ACR\u002FEULAR classification criteria of SSc; b) mRSS score \\>10; c) at least one vital organ involvement besides the skin; d)relapsed or refractory to at least one immunosuppressant or biologic.\n* pSS specfic: a)Fulling the 2016 EULAR\u002FACR classification critieria for pSS; b) anti-Ro\u002Fanti-SSA antibody positive; c) ESSDAI score ≥5 ; d)relapsed or refractory to at least one immunosuppressant or biologic.\n\nExclusion Criteria:\n\n* Active uncontrolled infection\n* Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load\n* Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load\n* HIV antibody positive\n* Syphilis antibody positive\n* Active tuberculosis, untreated or inadequately treated latent tuberculosis infection (LTBI)\n* History of serious infection within 3 months prior to screening (defined as requiring hospitalization or intravenous antimicrobial therapy), or history of oral antimicrobial therapy within 1 month prior to screening (e.g., viral infections, opportunistic infections, including but not limited to severe cytomegalovirus or herpes virus infections)\n* Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block)\n* Uncontrolled hypertension (blood pressure ≥160\u002F100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes or other endocrine diseases, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment\n* history of organ transplant\n* Pregnancy or lactating women\n* Use of any other experimental medication within 4 weeks or 5 half-lives prior to start of study drug\n* Use of biologics within 10 weeks, stem cell transplant within 6 months prior to the start of study drug\n* Prior CAR-T treatment\n* Received live or attenuated vaccine within 4 weeks of Cycle 1 Day 1\n* Presence of other autoimmune or auto-inflammatory diseases that may affect study assessments, such as rheumatoid arthritis, gout, or active fibromyalgia syndrome.\n* Limited to patients diagnosed with SSc: at risk for scleroderma renal crisis; SSc-associated gastric antral vascular ectasia; Severe gastrointestinal involvement leading to malabsorption or intestinal failure\n* Limited to patients diagnosed with pSS: primary biliary cholangitis",{"count":539,"type":22},44,[25],"This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-CD19-GDT in relapsed\u002Frefractory autoimmune diseases.",[182,543],"Primary Sjogren's Syndrome","2025-09-10",{"date":546,"type":33},"2025-09-11",{"date":548,"type":22},"2025-10",{"date":550,"type":22},"2028-12",{"name":39,"class":40},""]