[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Tongji Hospital, Tongji University School of Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":183},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,40,69,93,120,141,162],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100622497","early-phase-1-th-car-027-for-grade-4-gliomas-100622497",false,"NCT07384390","TH-CAR-027 for Grade 4 Gliomas","An Open-Label, Dose-Escalation, Multiple Administration, Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Anti-tumor Activity of TH-CART-027 Cell Injection in Subjects With Recurrent or Progressive Grade 4 Glioma","Inclusion Criteria:\n\n* 1\\. Voluntarily participate in the clinical trial; fully understand and are informed about this study and sign the informed consent form; willing and able to comply with and complete all trial procedures.\n\n  2\\. Male or female patients aged ≥18 years and ≤75 years. 3. Disease Status: Diagnosis of Grade 4 glioma as defined by the 2021 WHO Classification of Tumors of the Central Nervous System, including but not limited to glioblastoma, Grade 4 astrocytoma, and diffuse hemispheric glioma. Subjects must have experienced relapse or progression following standard therapy and are unsuitable for or refuse further surgical resection. Subjects with specific genetic mutations (e.g., NTRK gene fusion or BRAF V600E mutation) must have progressed after receiving corresponding targeted therapy to be eligible. Documentation of relapse\u002Fprogression must include imaging (MRI or PET) or histopathological confirmation.\n\n  4\\. B7-H3 Expression: ≥30% positivity for B7-H3 molecule in primary\u002Frelapsed tumor tissue by pathological testing. B7-H3 positivity is defined as: the percentage of B7-H3-positive tumor cells among total viable tumor cells in non-necrotic tumor tissue areas ≥30%.\n\n  5\\. Karnofsky Performance Status (KPS) score ≥60, or Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\n  6\\. Adequate venous access for peripheral blood mononuclear cell (PBMC) collection.\n\n  7\\. Left ventricular ejection fraction (LVEF) ≥40% by cardiac ultrasound within one month prior to screening.\n\n  8\\. Resting oxygen saturation ≥95% while breathing room air. 9. Laboratory tests must meet the following criteria within the specified timeframe prior to screening:\n  1. Hematological Function: Absolute neutrophil count (ANC)≥1.5×10\\^9\u002FL, hemoglobin ≥90 g\u002FL, platelet count≥100×10\\^9\u002FL, absolute lymphocyte count≥0.15×10\\^9\u002FL. No transfusion,granulocyte (macrophage)colony-stimulating factor, recombinant human erythropoietin, recombinant human thrombopoietin, thrombopoietin receptor agonist, recombinant human interleukin-11, or other supportive therapy within 14 days prior to the test.\n  2. Liver Function: Total bilirubin≤1.5×upper limit of normal (ULN) (except for patients with Gilbert's syndrome characterized by persistent or recurrent unconjugated hyperbilirubinemia in the absence of hemolysis or hepatic pathology); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN.\n  3. Renal Function: Serum creatinine ≤1.5×ULN.\n  4. Coagulation: Prothrombin time (PT) or activated partial thromboplastin time (aPTT) or international normalized ratio (INR) ≤1.5 ×ULN, in the absence of therapeutic anticoagulation.\n\n     10\\. Female subjects of childbearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. Female subjects of childbearing potential must use highly effective contraception from the start of the trial until 6 months after the last dose of study treatment. Sexually active males, who have not undergone vasectomy, must agree to use barrier contraception from the start of the trial until 6 months after the last dose of study treatment.\n\n     Exclusion Criteria:\n\n     Subjects with a known history of severe allergy to any component of the investigational product.\n\n     Pregnant or lactating women. Body weight \\\u003C40 kg.\n\n     Viral Infections:\n\n  \u003C!-- -->\n\n  1. Seropositivity for HIV antibody or positive serological test for Treponema pallidum (syphilis).\n  2. Hepatitis B surface antigen (HBsAg) positivity with peripheral blood HBV DNA levels above the upper limit of normal.\n  3. Hepatitis C virus (HCV) antibody positivity with detectable peripheral blood HCV RNA.\n\n     Medical History and Concurrent Conditions:\n\n  \u003C!-- -->\n\n  1. Having undergone carmustine wafer implantation surgery within the past 6 months.\n  2. Known or suspected active autoimmune diseases, including but not limited to Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.\n  3. Current requirement for systemic immunosuppressive therapy or, in the investigator's judgment, a need for long-term immunosuppressant use during the study period. Intermittent use of topical, inhaled, or intranasal corticosteroids is allowed.\n  4. Uncontrolled psychiatric disorders. Or subjects with a medical or psychiatric history that, in the investigator's opinion, could increase the risk associated with study participation or administration of the study drug, or could interfere with the interpretation of results.\n  5. Toxicities from prior anticancer therapy have not recovered to ≤ Grade 1 per CTCAE version 5.0 (except for alopecia and other events deemed tolerable by the investigator).\n  6. Participation in another interventional clinical trial within the past 1 month.\n  7. Prior treatment with any CAR-T therapy or other gene therapy.\n  8. Any severe or poorly controlled medical condition that, in the investigator's opinion, may increase the risk associated with study participation or study drug administration, or impair the subject's ability to receive the investigational product. This includes, but is not limited to, cardiovascular\u002Fcerebrovascular diseases, renal insufficiency, pulmonary embolism, coagulopathy or requirement for long-term anticoagulation therapy, active or uncontrolled infection requiring systemic treatment.\n  9. History or presence of other malignancies within the past 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ (e.g., cervical, bladder, breast).","ALL","18 Years","75 Years",{"count":20,"type":21},21,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This is an open-Label, dose-escalation, multiple administration, exploratory clinical study to evaluate the safety, tolerability, and anti-tumor activity of TH-CART-027 cell injection in subjects with recurrent or progressive grade 4 glioma",[27],"R\u002FR Grade 4 Glioma","NOT_YET_RECRUITING","2026-02-02",{"date":31,"type":32},"2026-02-04","ACTUAL",{"date":34,"type":21},"2026-01-30",{"date":36,"type":21},"2029-08-31",{"name":38,"class":39},"Shanghai Tongji Hospital, Tongji University School of Medicine","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100597870","multi-omics-characterization-and-model-construction-of-colchicine-anti-inflammatory-therapy-efficacy-in-acs-patients-100597870","NCT07064109","Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients","Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in Acute Coronary Syndromes Patients","MCM-CATE-ACS","Inclusion Criteria:\n\n* Between the ages of 18 and 80\n* ACS (STEMI or NSTE-ACS)\n* Patients to receive standardised drug therapy\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Any contraindication to colchicine or known intolerance to colchicine\n* Has been using colchicine for a prolonged period of time for other medical conditions\n* Women of childbearing age who are pregnant, breastfeeding or not using effective contraception\n* Coronary artery bypass grafting within the last 3 years or planned\n* Severe hepatic impairment: elevated serum alanine aminotransferase and\u002For aminotransferase (ALT) and\u002For aminotransferase (AST) levels of up to three times the upper limit of normal\n* Severe renal impairment: eGFR \\\u003C30mL\u002Fmin\u002F1.73m2\n* Thrombocytopenia (platelet count less than 100\\*10⁹\u002FL)\n* Active diarrhoea\n* Infectious diseases: presence of uncontrollable infectious diseases\n* Immune-related diseases: known immune diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumours, etc.\n* Strong CYP3A4 or P glycoprotein inhibitors (e.g., cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) are already in use and no alternative medications can be administered\n* Planning to use systemic anti-inflammatory therapies such as NSAIDs, hormones, immunomodulators and chemotherapeutic agents","80 Years",{"count":50,"type":21},380,[52],"NA","The aim of this prospective cohort study was to investigate the multi-omics characteristics of the efficacy of colchicine treatment in patients with ACS and to construct a model of efficacy. The main questions the study aims to answer are\n\n\\- Specific mechanisms of colchicine therapy in patients with ACS; Mechanism-based modelling to identify the population that benefits from colchicine treatment.",[55],"ACS - Acute Coronary Syndrome",[57,58],"ACS","colchicine","RECRUITING","2025-09-09",{"date":62,"type":32},"2025-09-15",{"date":64,"type":32},"2025-07-01",{"date":66,"type":21},"2027-07-01",{"name":38,"class":39},1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":68},"100596266","phase-1-a-clinical-study-exploring-universal-car-t-cell-in-patients-with-relapsedrefractory-b-cell-acute-lymphoblastic-leukemia-100596266","NCT07043218","A Clinical Study Exploring Universal CAR-T Cell in Patients With Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia","A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of Universal CAR-T Cell in Patients With CD19 and\u002For CD20 Positive Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia.","Inclusion Criteria:\n\n1. Participants must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the study visit schedule and other protocol requirements\n2. 18-75 years old;\n3. Histologically or cytologically confirmed B-ALL;\n4. Previously received at least 2 lines of systemic therapy;\n5. Expected survival \\> 12 weeks;\n6. Eastern Cooperative Oncology Group (ECOG) score 0-2;\n7. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to receiving preconditioning therapy。Both male and Female are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating sperm donation or eggs for 1 year after receiving study treatment infusion during the study.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis Cvirus infection (HCV antibody and HCV-DNA positive);\n3. Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);\n4. Participants' toxicities caused by previous treatment did not recover to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade1, except alopecia and other events that are judged tolerable by the investigator;\n5. Patients with isolated extramedullary lesions;\n6. Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent;\n7. Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or have other previous history of severe allergy such as anaphylactic shock;\n8. Patients with heart disease in the 6 months prior to screening;\n9. Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years;\n10. Serious pulmonary diseases that are judged by the investigator to potentially endanger the patient's life when participating in the study.",{"count":77,"type":21},36,[79],"PHASE1","A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT119X(including CT1190-P and CT1192) CAR-T Cell therapy, in Patients with Relapsed\u002FRefractory B-cell acute lymphoblastic leukemia.",[82],"B-cell Acute Lymphoblastic Leukemia",[84],"CT119X","2025-06-22",{"date":87,"type":32},"2025-06-29",{"date":89,"type":21},"2025-07-10",{"date":91,"type":21},"2027-06-30",{"name":38,"class":39},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":100,"maxAge":18,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":68},"100592014","phase-1-efficacy-and-safety-evaluation-of-u01sscart-19-in-b-cell-lymphoma-100592014","NCT06987916","Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma","A Single-Arm, Open-Label Clinical Study on the Efficacy and Safety of U01 (ssCART-19) in the Treatment of Relapsed or Refractory B-Cell Lymphoma","Inclusion Criteria:\n\n1. Participants must voluntarily sign the informed consent form (ICF) and demonstrate good compliance.\n2. Participants must meet the following requirements:\n\n   1. Age ≥2 years and ≤75 years at the time of signing the ICF (both sexes eligible). For minors (\\\u003C18 years), the legal guardian must sign after full disclosure; minors with decision-making capacity must co-sign with their guardians.\n   2. Confirmed diagnosis of B-cell lymphoma according to the NCCN Clinical Practice Guidelines for B-Cell Lymphomas (3rd Edition, 2024) .\n   3. Prior treatment requirements :\n\n   Failure to achieve partial response (PR) after first-line therapy, or relapse within 12 months post-first-line therapy; Relapsed\u002Frefractory B-cell lymphoma after second-line therapy (one standard chemotherapy regimen + one salvage regimen).\n\n   Prior treatments must include CD20 monoclonal antibody (unless CD20-negative tumor confirmed by the investigator) and anthracycline-based regimens .\n\n   Additionally, meet one of the following:\n\n   i. Ineligible for autologous stem cell transplantation (ASCT); ii. Refusal of ASCT; iii. Post-ASCT relapse. d) Refractory\u002Frelapsed status at screening: Relapse: Disease progression (PD) after achieving PR or complete response (CR);\n\n   Refractory:\n\n   i. No response to last-line therapy (PD during\u002Fafter treatment, or stable disease \\[SD\\] lasting \\\u003C6 months); ii. Post-ASCT relapse\u002FPD (biopsy-confirmed), including relapse\u002FPD within 12 months post-ASCT with SD\u002FPD after salvage therapy2.\n3. CD19 positivity confirmed by immunohistochemistry (IHC) of tumor tissue (preferably within 6 months).\n4. At least one measurable lesion assessed by the Lugano Lymphoma Response Criteria (Cheson 2014) .\n5. ECOG performance status score 0-3 .\n6. Adequate bone marrow reserve at screening:\n\n   Absolute lymphocyte count (ALC) ≥0.3×10⁹\u002FL ; Platelet count (PLT) ≥30×10⁹\u002FL .\n7. Adequate organ function:\n\n   AST\u002FALT ≤3×ULN (≤5×ULN if due to tumor infiltration); Total bilirubin ≤2×ULN (≤3×ULN for Gilbert syndrome with direct bilirubin ≤1.5×ULN); Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula); Oxygen saturation \\>91% on room air (dyspnea grade ≤1); Left ventricular ejection fraction (LVEF) ≥50% ; INR ≤1.5×ULN and APTT ≤1.5×ULN .\n8. Negative pregnancy test (blood\u002Furine) within 7 days before CAR-T infusion for women of childbearing potential. All participants must agree to use effective contraception during the study and for ≥1 year post-treatment.\n9. Adequate venous access for leukapheresis or blood collection, with no contraindications to leukapheresis.\n10. Expected survival ≥3 months .\n\nExclusion Criteria:\n\n1. Concurrent malignancies , except for:\n\n   Malignancies with disease-free survival (DFS) \\>3 years ; Carcinoma in situ ;\n2. Active viral infections :\n\n   Hepatitis B : Positive for HBe-Ab and\u002For HBc-Ab with HBV-DNA \\> lower limit of quantitation (LLOQ) ; Hepatitis C : Positive HCV-Ab with HCV-RNA \\> LLOQ ; Positive Treponema pallidum antibody (TP-Ab); Positive HIV antibody ;\n3. Uncontrolled infections (bacterial, fungal, viral, mycoplasmal, or others) as determined by the investigator;\n4. Clinically significant CNS diseases (current or history), including:\n\n   Epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disorders, or CNS-related autoimmune diseases , deemed uncontrolled by the investigator;\n5. Cardiovascular exclusion criteria :\n\n   Cardiac angioplasty\u002Fstent placement within 12 months prior to signing ICF ; NYHA Class II-IV congestive heart failure , myocardial infarction, unstable angina, or other clinically significant cardiac history; QTe interval ≥480 ms (Fridericia correction) or LVEF \\\u003C50% at screening;\n6. Primary immunodeficiency ;\n7. Severe immediate hypersensitivity to any study drug;\n8. Live vaccine administration within 6 weeks prior to screening ;\n9. Pregnancy or lactation ;\n10. Active autoimmune diseases ;\n11. Participation in another interventional clinical trial within 30 days prior to ICF signing ;\n12. Other conditions deemed ineligible by the investigator.","2 Years",{"count":102,"type":21},50,[79,104],"PHASE2","This is an open-label phase1 study to assess the safety and efficacy of U01(ssCART-19) cell therapy in the treatment of patients with refractory or recurrent B-cell lymphoma .",[107],"B Cell Lymphoma",[109,110,111],"ssCART-19","Relapsed or Refractory B-Cell Lymphma","IL-6","2025-05-31",{"date":114,"type":32},"2025-06-05",{"date":116,"type":32},"2025-04-22",{"date":118,"type":21},"2030-04-22",{"name":38,"class":39},{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":68},"100589208","early-phase-1-an-exploratory-clinical-study-of-the-efficiency-and-safety-of-th027-in-the-treatment-of-relapsedrefractory-solid-tumors-100589208","NCT06951425","An Exploratory Clinical Study of the Efficiency and Safety of TH027 in the Treatment of Relapsed\u002FRefractory Solid Tumors","A Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerability and Antitumor Activity of TH027 CAR-T Cells (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors","Inclusion Criteria:\n\n* 1.The patients were aged from 18 to 75 years old (including the cut-off value), and the gender was not limited;\n* 2.The expected survival time was more than 12 weeks;\n* 3.ECOG score was 0-2;\n* 4.One of the following tumor types was confirmed by pathology: osteosarcoma, neuroblastoma, gastric cancer or lung cancer, and the positive rate of CD276 expression in tumor tissue was more than 30% by immunohistochemistry;\n* 5.Patients with ineffective standard treatment methods (such as postoperative recurrence, chemotherapy, radiotherapy, and progression after targeted drugs);\n* 6.According to RECIST 1.1, there was at least one measurable lesion (the longest diameter of solid lesion \\>=10 mm, or the short diameter of lymph node lesion \\>=15 mm);\n* 7.The function of main organs was normal (white blood cell count \\>= 3 × 10\\^9 \u002F L, neutrophil count \\>= 1.5 × 10\\^9 \u002F L, hemoglobin \\>= 8.5g\u002Fdl, platelet count \\>= 80 × 10\\^9 \u002F L and lymphocyte count at 1 × 10\\^9 \u002F L (including) \\~ 4 × 10\\^9 \u002F L (inclusive);\n* 8.The liver and kidney function and cardiopulmonary function meet the following requirements:\n* Urea and serum creatinine \\\u003C= 1.5 × ULN；\n* Left ventricular ejection fraction \\>= 50%;\n* Baseline oxygen saturation \\>= 94%;\n* Total bilirubin \\\u003C= 1.5 × ULN； ALT and AST \\\u003C= 2.5 × ULN；\n* 9.The patient or legal representative can fully understand the significance and risk of this trial and has signed the informed consent.\n\nExclusion Criteria:\n\n* 1.Patients with history of immune deficiency or autoimmune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); Patients with graft-versus-host disease (GVHD) or need immunosuppressive agents;\n* 2.There was a history of other second malignancies in 5 years before screening;\n* 3.Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) were positive, and the peripheral blood HBV DNA titer was not within the normal reference value; HCV antibody and HCV RNA in peripheral blood were positive; HIV antibody positive patients; Syphilis was positive;\n* 4.Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification \\>= III), severe arrhythmia;\n* 5.Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;\n* 6.Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);\n* 7.Pregnant or lactating women, female subjects who plan to conceive within one year after cell transfusion, or male subjects whose partners plan to conceive within one year after cell transfusion;\n* 8.Patients who had received CAR-T therapy or other gene modified cell therapy before screening;\n* 9.The subjects who were receiving systemic steroid treatment within 7 days before the screening or who needed long-term systemic steroid treatment (except inhalation or local use) were determined by the researchers;\n* 10.The ascites increased gradually after 2 weeks of conservative treatment (such as diuresis, sodium restriction, excluding ascites drainage);\n* 11.According to the judgment of the researcher, it does not conform to the situation of cell preparation;\n* 12.Other researchers think that it is not suitable for inclusion.",{"count":128,"type":21},24,[24],"This is a Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerabilityand Antitumor Activity of TH027 CAR-T Cell lnjection (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors.",[132],"Solid Tumors","2025-05-12",{"date":135,"type":32},"2025-05-13",{"date":137,"type":21},"2025-06-01",{"date":139,"type":21},"2028-11-30",{"name":38,"class":39},{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":4},"100555996","early-phase-1-an-exploratory-clinical-study-evaluating-the-safety-and-efficacy-of-intravenous-anti-cd20cd30-car-t-cell-infusion-in-relapsedrefractory-lymphoma-patients-100555996","NCT06519344","An Exploratory Clinical Study Evaluating the Safety and Efficacy of Intravenous Anti-CD20\u002FCD30-CAR-T Cell Infusion in Relapsed\u002FRefractory Lymphoma Patients.","Inclusion Criteria:\n\n(1) Voluntary participation in the clinical study; complete understanding by self or legally authorized guardian, informed of the study, and signing the Informed Consent Form (ICF); willing and able to comply with all trial procedures.\n\n(2) Age between 18 and 70 years.\n\n(3) Patients refractory or relapsed after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation), and unsuitable for other treatment options such as second hematopoietic stem cell transplantation. Refractory\u002Frelapsed lymphoma is defined as:\n\n1. No response to first-line therapy (primary refractory disease, excluding subjects intolerant to first-line therapy):\n\n   \\- Progression of Disease (PD) assessment after first-line treatment\n   * Best response of Stable Disease (SD) after at least 4 cycles of first-line treatment (e.g., 4 cycles of RCHOP), with SD maintenance duration not exceeding 6 months after the last dose.\n2. No response to second-line or subsequent therapies:\n\n   * PD as best response to the most recent treatment regimen\n   * Best response of SD after at least 2 cycles of last-line treatment, with SD maintenance duration not exceeding 6 months after the last dose.\n3. Refractory post autologous stem cell transplantation (ASCT):\n\n   * Disease progression or relapse ≤12 months after ASCT (relapsing subjects must have biopsy-proven relapse)\n   * If salvage therapy is performed post-ASCT, subjects must have had no response or relapse after the last-line treatment.\n   * Relapsed or refractory disease after two or more lines of systemic therapy.\n\n     (4) Lymphoma patients with target antigens meeting the following criteria:\n   * CD20\u002FCD30 double-positive lymphomas\n   * Relapse after anti-CD19-CAR-T cell therapy, and CD20-positive lymphomas\n   * Never received anti-CD19-CAR-T cell therapy, CD20-positive lymphomas\n   * CD30-positive Hodgkin lymphoma.\n\n     (5) Included lymphoma subtypes:\n   * DLBCL-NOS (Diffuse Large B-Cell Lymphoma, not otherwise specified)\n   * Primary mediastinal large B-cell lymphoma (PMBCL)\n   * Transformed follicular lymphoma (TFL), previously treated with follicular lymphoma chemotherapy, subsequently transformed into DLBCL, refractory disease\n   * Mantle cell lymphoma\n   * High-grade B-cell lymphoma\n   * Chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL)\n   * Hodgkin lymphoma (HL).\n\n     (6) ECOG performance status ≤2.\n\n     (7) Expected survival of at least 12 weeks.\n\n     (8) Adequate venous access (for single collection), and no other contraindications for blood cell separation.\n\n     (9) Laboratory requirements at screening, with no hematologic evaluation within 7 days of receiving growth factors (long-acting granulocyte colony-stimulating factor (G-CSF\u002FPEG-CSF) requires a 2-week interval):\n   * Absolute neutrophil count ≥1.0×10\\^9\u002FL;\n   * Hemoglobin ≥60 g\u002FL (without red blood cell transfusion within 7 days);\n   * Platelets ≥50×10\\^9\u002FL (CLL indication unrestricted);\n   * Serum total bilirubin ≤1.5× upper limit of normal (ULN); or ≤3× ULN if liver tissue invasion by tumor;\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5× ULN, AST\u002FALT ≤5× ULN if liver tissue invasion by tumor;\n   * Creatinine \\\u003C1.5× ULN and estimated glomerular filtration rate ≥60 mL\u002Fminute.\n\n     (10) Left ventricular ejection fraction ≥45%, echocardiogram (ECHO) showing no clinically significant pericardial effusion (excluding minimal or physiological effusions), and no clinically significant findings on electrocardiogram.\n\n     (11) Baseline oxygen saturation \\>92% without supplemental oxygen.\n\n     (12) Women of childbearing potential must have a negative serum or urine pregnancy test result (women who have undergone surgical sterilization or who are at least 2 years postmenopausal are not considered of childbearing potential).\n\nExclusion Criteria:\n\nHere is the translation of the exclusion criteria for participants in a clinical study:\n\n1. Evidence of central nervous system lymphoma on brain MRI; active primary central nervous system DLBCL, unless CNS involvement has been effectively treated (i.e., participant is asymptomatic) and there has been a local treatment interval of \\>4 weeks prior to enrollment.\n2. Active central nervous system diseases such as epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any autoimmune diseases with central nervous system involvement.\n3. History of or concurrent malignancies other than CD19+ malignancies.\n4. Clinically significant cardiac disease, or arrhythmias not controlled by medication.\n5. Presence or suspicion of uncontrolled fungal, bacterial, viral, or other infections requiring intravenous antibiotics; simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed.\n6. Hepatitis B (positive hepatitis B surface antigen and hepatitis B DNA \\>1000 copies\u002FmL) and hepatitis C (positive hepatitis C antibody).\n7. Presence of any indwelling catheters or drainage tubes (e.g., percutaneous nephrostomy tube, Foley catheter, bile drainage tube, pleural\u002Fperitoneal\u002Fpericardial catheter); specialized central venous access devices like Port-A-Cath® or Hickman® catheters are allowed.\n8. Use of the following medications prior to:\n\n1\\) Ibrutinib within 1 day before apheresis. 2) Idelalisib (oral PI3Kδ inhibitor) within 2 days before apheresis. 3) Short-acting targeted therapy (such as tyrosine kinase inhibitors) within 72 hours before apheresis.\n\n4\\) Venetoclax (BCL-2 inhibitor) within 4 days before apheresis. 5) Long-acting growth factors (such as pegfilgrastim) within 14 days before apheresis, or short-acting growth factors or mobilizing agents (such as granulocyte colony-stimulating factor (G-CSF)\u002Ffilgrastim) within 5 days before apheresis.\n\n6\\) Pharmacologic doses of corticosteroid therapy (\\>5 mg\u002Fday prednisone or equivalent) and other immunosuppressive drugs within 7 days before enrollment.\n\n7\\) Radiotherapy within 14 days before enrollment. 8) Systemic cytotoxic drugs within 14 days before enrollment, including daily or weekly low-dose maintenance chemotherapy (e.g., cyclophosphamide, fludarabine, bendamustine, chlorambucil, methotrexate, vinblastine).\n\nIf bridging therapy is administered post-apheresis, there must be at least a 7-day interval between bridging therapy and CAR-T cell infusion.\n\n9\\) Anti-PD1 or anti-PDL1 therapy within 4 weeks before enrollment. 10) Vaccination within 4 weeks before enrollment. 11) Donor lymphocyte infusion (DLI) within 4 weeks before enrollment. 12) Immunostimulatory or immunosuppressive therapy within 3 months before enrollment (such as interferon-α, interferon-β, IL-2, lenalidomide, efalizumab, alemtuzumab, cyclosporine, or methotrexate).\n\n(9) Active graft-versus-host disease (GVHD) using the CIBMTR acute GVHD grading system ≥ grade 2 or requiring systemic steroids greater than physiological doses.\n\n(10) History in the past 2 years of autoimmune diseases causing end-organ damage or requiring systemic immunosuppressive\u002Fdisease-modifying agents, such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus.\n\n(11) History in the past 12 months of myocardial infarction, cardiac vascular procedures or stent implantation, unstable angina, or other clinically significant cardiac diseases.\n\n(12) History of genetic syndromes with bone marrow failure, such as Fanconi anemia, Costello syndrome, Shwachman-Diamond syndrome.\n\n(13) Symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation therapy within 6 months before enrollment. Subjects requiring prophylactic anticoagulation are allowed.\n\n(14) History of concurrent or prior malignancies (excluding basal cell carcinoma of the skin, in situ carcinoma of the breast\u002Fcervix, and other malignancies effectively controlled without treatment within the past five years).\n\n(15) Use of other investigational medicinal products within 30 days before screening.\n\n(16) Pregnant or lactating women of childbearing potential. Women who have undergone surgical sterilization or who are at least 2 years postmenopausal are not considered of childbearing potential.\n\n(17) Participants unwilling to use contraception from agreeing to treatment until completion of lymphocyte depletion chemotherapy or CAR-T cell infusion within 12 months (whichever is longer).\n\n(18) Any medical activities that could potentially interfere with the safety or efficacy evaluation of the study treatment.\n\n(19) According to the investigator's judgment, participants who are unlikely to complete all study visits or procedures required by the protocol (including follow-ups), or comply with the requirements of participating in the study.","70 Years",{"count":149,"type":21},12,[24],"This study is a single-center,open-label,single-dose clinical trial of anti-CD20\u002FCD30-CAR-T cell therapy in relapsed\u002Frefractory B-cell tumor patients after lymphocyte depletion pre-treatment.\n\nIn this study phase,a traditional \"3+3\"trial design is employed for dose escalation.",[153],"B Cell Malignancies","2024-07-19",{"date":156,"type":32},"2024-07-25",{"date":158,"type":21},"2024-07-31",{"date":160,"type":21},"2027-07-30",{"name":38,"class":39},{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":68},"100544920","early-phase-1-anti-cd19-car-t-cells-in-relapsedrefractory-b-cell-tumor-patients-100544920","NCT06375161","Anti-CD19-CAR-T Cells in Relapsed\u002FRefractory B-cell Tumor Patients.","An Exploratory Clinical Study Evaluating the Safety and Efficacy of Infusion of Anti-CD19-CAR-T Cells in Relapsed\u002FRefractory B-cell Tumor Patients.","Inclusion Criteria:\n\n1. Voluntary participation in the clinical trial; the individual or legal guardian fully understands and consents to the study by signing the Informed Consent Form (ICF); willing and able to comply with all trial procedures.\n2. Age between 18-70 years.\n3. Patients who are refractory or relapsed after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation), and not suitable for other treatment options such as a second hematopoietic stem cell transplantation.\n\n   1. Relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (ALL) is defined as one of the following:\n\n      \\- Primary refractory disease\n\n      \\- First relapse if the first remission was ≤12 months\n      * Relapse or refractory disease after two or more lines of systemic therapy\n      * Relapse or refractory disease after allogeneic transplantation, provided that at least 100 days have elapsed since transplantation at the time of enrollment, and no immunosuppressive drugs have been used for at least 4 weeks prior to enrollment, except for low-dose steroids (≤5 mg prednisone or equivalent).\n   2. Subjects with Ph+ B-cell ALL who are intolerant or ineligible for treatment with tyrosine kinase inhibitors (TKIs), or have relapsed\u002Frefractory disease after receiving at least two different TKI treatments, are eligible.\n   3. Relapsed\u002Frefractory B-cell non-Hodgkin lymphoma (NHL) is defined as one of the following:\n\n      1. No response to first-line treatment (primary refractory disease); excluding subjects intolerant to first-line chemotherapy - PD as the best response to first-line treatment - Best response after at least 4 cycles of first-line treatment (such as 4 cycles of RCHOP) is SD, and the duration of SD after the last dose does not exceed 6 months.\n      2. No response to second-line or subsequent treatments - PD as the best response to the most recent treatment regimen - Best response after at least 2 cycles of last-line treatment is SD, and the duration of SD after the last dose does not exceed 6 months.\n      3. Refractory after ASCT\n\n         \\- Disease progression or relapse ≤12 months post-ASCT (relapse must be confirmed by biopsy).\n         * If salvage therapy is given post-ASCT, subjects must have had no response or relapse after the last-line treatment.\n4. Bone marrow smear reports showing tumor cells ≥5% in ALL patients.\n5. Patients with refractory or relapsed NHL meet one of the following subtypes:\n\n1\\) DLBCL-NOS. 2) Primary mediastinal large B-cell lymphoma (PMBCL). 3) Transformed follicular lymphoma (TFL), previously treated with follicular lymphoma chemotherapy, subsequently transformed into refractory disease after DLBCL.\n\n4\\) Mantle cell lymphoma. 5) High-grade B-cell lymphoma. 6) CLL\u002FSLL.\n\n(6) ECOG performance status ≤2.\n\n(7) Estimated life expectancy of at least 12 weeks.\n\n(8) Adequate venous access (for single collection) and no other contraindications to blood cell separation.\n\n(9) Laboratory test results at screening must meet the following requirements, and subjects must not have received colony-stimulating factors (G-CSF\u002FPEG-CSF) within 2 weeks prior to hematological assessment (except for low-dose steroids):\n\n1\\) Absolute neutrophil count ≥1.0×10\\^9\u002FL, ALL eligibility to be determined by the investigator.\n\n2\\) Hemoglobin ≥60 g\u002FL (without red blood cell transfusion within 14 days). 3) Platelets ≥50×10\\^9\u002FL, ALL eligibility to be determined by the investigator. 4) Absolute lymphocyte count (ALC) ≥ 0.5×10\\^9\u002FL; if insufficient, and T-cell proportion is high in the lymphocyte subset, the investigator can discuss with the sponsor.\n\n5\\) Serum total bilirubin ≤1.5× upper limit of normal (ULN). 6) Aspartate transaminase (AST), alanine transaminase (ALT) ≤2.5× ULN. 7) Creatinine \\\u003C1.5× ULN and creatinine clearance ≥60 mL\u002Fminute.\n\n(10) Left ventricular ejection fraction ≥45%, echocardiography (ECHO) confirms no clinically significant pericardial effusion (except for trace or physiological), and electrocardiography results have no clinical significance.\n\n(11) Baseline oxygen saturation in room air \\>92%.\n\n(12) Women of childbearing potential must have negative serum or urine pregnancy tests (women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered women of childbearing potential).\n\nExclusion Criteria:\n\n(1) ALL with central nervous system abnormalities, excluding clinically evident neurological changes CNS-2 and CNS-3.\n\n1\\) CNS-3 disease, defined as detectable tumor cells in the cerebrospinal fluid (CSF), with ≥5 WBCs per mm3, with or without neurological changes.\n\n2\\) CNS-2 disease, defined as detectable tumor cells in the CSF, with \\\u003C5 WBCs per mm3, and neurological changes.\n\nNote: Subjects with CNS-1 (no tumor cells detected in CSF) and CNS-2 with no clinically evident neurological changes are eligible for this study.\n\n(2) Evidence of central nervous system lymphoma on brain MRI; active primary central nervous system DLBCL, unless the central nervous system involvement has been effectively treated (i.e., participants are asymptomatic), and \\>4 weeks have elapsed since local treatment before enrollment.\n\n(3) Active central nervous system diseases such as epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the central nervous system.\n\n(4) History of or concurrent malignancies other than CD19+ malignancies.\n\n(5) Clinically significant cardiac diseases, or arrhythmias not controlled by medication.\n\n(6) Presence or suspicion of uncontrolled fungal, bacterial, viral, or other infections, or requiring intravenous antibiotic therapy; simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed if responsive to treatment and after consultation with the sponsor's medical monitor.\n\n(7) Hepatitis B (positive for hepatitis B surface antigen and\u002For positive for hepatitis B core antibody with hepatitis B DNA \\>1000 copies\u002Fml) and hepatitis C (positive for hepatitis C antibody); syphilis, human immunodeficiency virus (HIV) infection.\n\n(8) Presence of any indwelling catheter or drainage tube (such as percutaneous nephrostomy tube, indwelling Foley catheter, bile drainage tube, or pleural\u002Fperitoneal\u002Fpericardial catheter); use of dedicated central venous access devices such as Port-A-Cath® or Hickman® catheters is allowed.\n\n(9) Prior medication:\n\n1. CD19-targeted therapy.\n2. Use of chlorambucil or cladribine within 3 months prior to enrollment, or use of PEG-asparaginase within 3 weeks prior to enrollment.\n3. Injection of live vaccines within 4 weeks prior to enrollment.\n4. Donor lymphocyte infusion (DLI) within 28 days prior to enrollment.\n5. Any drugs used for GVHD treatment within 4 weeks prior to enrollment (such as calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, or salidroside), or use of immunosuppressive antibodies (such as anti-CD20, anti-tumor necrosis factor, anti-interleukin-6, or anti-interleukin-6 receptor) within 4 weeks prior to enrollment.\n6. Immunostimulatory or immunosuppressive therapy within 4 weeks prior to enrollment (such as interferon-alpha, interferon-beta, IL-2, enoxaparin, efalizumab, alemtuzumab, tacrolimus, or mycophenolate).\n7. Any systemic inhibitory\u002Fstimulatory immune checkpoint molecule therapy within 4 weeks prior to enrollment (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc.).\n8. Use of systemic cytotoxic drugs within 2 weeks prior to enrollment, including daily or weekly low-dose maintenance chemotherapy (such as cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or mephalan, vincristine, etc.).\n9. Long-acting growth factors within 14 days prior to single collection (such as pegfilgrastim) or short-acting growth factors within 5 days prior to single collection or drugs used for cell mobilization (such as G-CSF\u002FPEG-CSF, plerixafor).\n10. Receipt of radiotherapy within 2 weeks prior to enrollment.\n11. Must avoid pharmacological doses of corticosteroids (\\>5 mg\u002Fday of prednisone or equivalent) and other immunosuppressive drugs within 7 days prior to single collection.\n12. Use of venetoclax (BCL-2 inhibitor) within 4 days prior to single collection.\n13. Short-acting targeted therapies (such as tyrosine kinase inhibitors) within 72 hours prior to single collection.\n14. Use of idelalisib (oral PI3Kδ inhibitor) within 2 days prior to single collection.\n15. Use of lenalidomide within 1 day prior to single collection.\n\n(10) Active graft-versus-host disease (GVHD) using CIBMTR acute GVHD grading system ≥ grade 2 or requiring systemic steroids greater than physiological doses.\n\n(11) History of autoimmune diseases in the past 2 years (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) resulting in end-organ damage or requiring systemic immunos uppressive\u002Fdisease-modifying therapy.\n\n(12) History of myocardial infarction, cardiac vascular surgery or stent implantation, unstable angina, or other clinically significant cardiac diseases within 12 months prior to enrollment.\n\n(13) History of genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Costello syndrome, Shwachman-Diamond syndrome, etc.\n\n(14) Symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within the past 6 months. Subjects need to be on prophylactic anticoagulation.\n\n(15) Past or present concurrent malignancies (excluding skin basal cell carcinoma, breast\u002Fcervical carcinoma in situ, and other malignancies that have not been treated and effectively controlled in the past five years).\n\n(16) Use of other investigational medicinal products within 30 days prior to screening.\n\n(17) Pregnant or lactating women of childbearing age, due to potential risks of chemotherapy to the fetus or infant. Women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered of childbearing potential.\n\n(18) Subjects unwilling to practice contraception from the agreement to treatment completion of conditional chemotherapy or CAR T infusion within 12 months (whichever is longer).\n\n(19) Any medical conditions that may interfere with the safety or efficacy assessment of the study treatment.\n\n(20) Subjects unlikely, in the investigator's judgment, to complete all protocol-required study visits or procedures, including follow-up, or comply with study requirements.\n\n(21) Previous use of any CAR-T cell products or other genetically modified T cell therapies.","18 Weeks","70 Weeks",{"count":149,"type":21},[24],"This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed\u002Frefractory B-cell tumor patients after Qinglin pre-treatment.\n\nIn this study phase, a traditional \"3+3\" trial design is employed for dose escalation.",[153],"2024-04-16",{"date":177,"type":32},"2024-04-19",{"date":179,"type":32},"2023-12-11",{"date":181,"type":21},"2039-12-10",{"name":38,"class":39},""]