[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chongqing Precision Biotech Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":588},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,40,71,93,114,132,157,183,209,230,255,278,295,313,341,365,386,403,422,453,474,496,519,539,563],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100643332","non-interventional-study-of-puzol-cel-for-cd19-positive-relapsedrefractory-b-cell-acute-lymphoblastic-leukemia-100643332",false,"NCT07637929","Non-Interventional Study of Puzol-cel for CD19-Positive Relapsed\u002FRefractory B-Cell Acute Lymphoblastic Leukemia","Non-Interventional Study of Puzolcabtagene Autoleucel Injection for CD19-Positive Relapsed\u002FRefractory B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Patients with r\u002Fr B-ALL who receive treatment with Pucicelant Injection at a research center commercially certified by Chongqing Precision Biotech in China, and whose bone marrow tumor cells are confirmed to express CD19 by flow cytometry\n* Patients with essentially normal function of vital organs\n* Patients who voluntarily participate in this study and sign the informed consent form. For patients under 18 years of age, informed consent must also be obtained from their legal guardians\n\nExclusion Criteria:\n\n* Patients who test positive for hepatitis C virus (HCV), human immunodeficiency virus (HIV), and Treponema pallidum (TP).","ALL",{"count":19,"type":20},200,"ESTIMATED","2 Years","OBSERVATIONAL","Establishing real-world data of Chinese patients with CD19-positive relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (r\u002Fr B-ALL) treated with Puzolcabtagene Autoleucel Injection to evaluate its effectiveness.",[25],"Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (r\u002Fr B-ALL)",[27],"Puzolcabtagene Autoleucel Injection","NOT_YET_RECRUITING","2026-06-04",{"date":31,"type":32},"2026-06-10","ACTUAL",{"date":34,"type":20},"2026-06",{"date":36,"type":20},"2032-12",{"name":38,"class":39},"Chongqing Precision Biotech Co., Ltd","INDUSTRY",{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100628033","phase-1-pic1-injection-therapy-for-relapsedrefractory-b-nhl-100628033","NCT07456371","PIC1 Injection Therapy for Relapsed\u002FRefractory B-NHL","Clinical Study of PIC1 Injection for the Treatment of Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* The patient (or their legally authorized representative) has voluntarily agreed to participate in this clinical trial and has signed the Informed Consent Form (ICF), indicating full understanding of the study's objectives and procedures.\n* Aged 18 to 75 years, regardless of gender.\n* Histologically or cytologically confirmed B-cell Non-Hodgkin Lymphoma (NHL) according to the WHO 2017 classification, including the following subtypes:\n\n  1. Diffuse Large B-Cell Lymphoma (DLBCL): Including DLBCL, not otherwise specified (DLBCL, NOS); DLBCL associated with chronic inflammation; Primary Cutaneous DLBCL, leg type; and EBV-positive DLBCL, NOS.\n  2. High-Grade B-Cell Lymphoma (HGBL): Including HGBL, NOS; and HGBL with MYC and BCL2 and\u002For BCL6 rearrangements.\n  3. Primary Mediastinal Large B-Cell Lymphoma.\n  4. T-cell\u002FHistiocyte-rich Large B-Cell Lymphoma.\n  5. Transformed DLBCL: DLBCL transformed from prior lymphomas (e.g., Follicular Lymphoma, Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma, Marginal Zone Lymphoma).\n  6. Follicular Lymphoma Grade 3b (FL3b).\n  7. Mantle Cell Lymphoma.\n* Patients must have received adequate prior therapy including an anti-CD20 monoclonal antibody and an anthracycline, unless contraindicated or intolerant (i.e., CD20-negative status, intolerance to anti-CD20 mAb, or contraindication to anthracyclines). Patients must meet the definition of Relapsed or Refractory (R\u002FR) disease:\n\n  1. Relapsed: Disease progression or recurrence after achieving a Complete Response (CR) to standard therapy.\n  2. Refractory: Best response of Stable Disease (SD) after at least 4 cycles of first-line therapy or at least 2 cycles of last-line therapy (≥2nd line), with SD duration ≤6 months after the last dose; or best response of Progressive Disease (PD) to the last treatment.\n  3. No response, disease progression, or relapse after Autologous Stem Cell Transplantation (ASCT).\n  4. Patients with transformed lymphoma who received chemotherapy prior to transformation and subsequently failed to achieve response, progressed, or relapsed after salvage therapy post-transformation.\n* CD19 positivity confirmed by immunohistochemistry (IHC) or flow cytometry.\n* ECOG performance status of 0 or 1.\n* Estimated life expectancy of ≥12 weeks.\n* At least one measurable lesion per the 2014 Lugano Criteria:\n\n  1. For nodal lesions: Longest diameter \\>1.5 cm.\n  2. For extranodal lesions: Longest diameter \\>1.0 cm.\n* Adequate major organ function defined as:\n\n  1. Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥40% by echocardiogram.\n  2. Renal function: Serum creatinine ≤2.0 × ULN or Creatinine Clearance ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n  3. Hepatic enzymes: ALT and AST ≤3.0 × ULN (or ≤5.0 × ULN for subjects with hepatic involvement).\n  4. Bilirubin: Total bilirubin ≤2.0 × ULN (or ≤3.0 × ULN for subjects with Gilbert's syndrome).\n  5. Oxygenation: Oxygen saturation (SpO2) ≥ 92% while breathing room air.\n  6. Hematology: Neutrophil Count ≥ 1.0 × 10\\^9\u002FL; Platelet count ≥ 75 × 10\\^9\u002FL; Hemoglobin ≥ 80 g\u002FL. (For subjects with bone marrow involvement: Neutrophil ≥ 0.5 × 10\\^9\u002FL and Platelet count ≥ 50 × 10\\^9\u002FL.)\n* Women of childbearing potential must have a negative pregnancy test. All subjects must agree to use a highly effective method of contraception from the time of signing the ICF until 1 year after the infusion of the investigational product.\n\nExclusion Criteria:\n\n* Received prior Chimeric Antigen Receptor T-cell (CAR-T) therapy or any other gene-modified cell therapy before screening.\n* Received any of the following anti-tumor therapies prior to PIC1 infusion:\n\n  1. medications (e.g., chemotherapy, targeted therapy) within 14 days or 5 half-lives (whichever is longer) before infusion. (excluding lymphodepleting chemotherapy and intrathecal chemotherapy for CNS lymphoma. And intrathecal chemotherapy must be discontinued at least 1 week prior to PIC1 infusion.)\n  2. Radiation therapy within 14 days before infusion.\n* Has any of the following cardiac conditions:\n\n  1. New York Heart Association (NYHA) Class III or IV congestive heart failure.\n  2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment.\n  3. Clinically significant ventricular arrhythmias, or a history of unexplained syncope (excluding cases caused by vasovagal reactions or dehydration).\n  4. History of severe non-ischemic cardiomyopathy.\n* Has an active or uncontrolled infection requiring systemic treatment within 1 week prior to screening.\n* Has Grade 2-4 acute GVHD or moderate-to-severe chronic GVHD within 4 weeks prior to screening.\n* Has experienced a cerebrovascular accident or seizure within 6 months prior to screening.\n* Has experienced a deep vein thrombosis or arterial embolism event within 6 months prior to screening.\n* Has a history of other malignancies except for: tumors with no evidence of active disease where treatment was completed \\>2 years ago; adequately treated carcinoma in situ of the cervix; basal cell or squamous cell skin cancer; radical prostatectomy; radical ductal carcinoma in situ.\n* Received a live attenuated vaccine within 4 weeks prior to screening.\n* Any other condition that, in the opinion of the Investigator, makes the subject unsuitable for participation in this study.","18 Years","75 Years",{"count":50,"type":20},18,"INTERVENTIONAL",[53],"PHASE1","This is an investigator-initiated trial aimed at assessing the safety and efficacy of PIC1 injection in the treatment of relapsed\u002Frefractory B-cell Non-Hodgkin Lymphoma.",[56],"Non-Hodgkin Lymphoma",[58,59,60],"CAR-T","CD19","in vivo","RECRUITING","2026-03-04",{"date":64,"type":32},"2026-03-06",{"date":66,"type":20},"2026-03",{"date":68,"type":20},"2029-02",{"name":38,"class":39},1,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":51,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":70},"100623935","phase-1-study-of-cd19-car-t-therapy-for-refractory-sle-100623935","NCT07403097","Study of CD19 CAR-T Therapy for Refractory SLE","Study of Autologous CD19-Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Age ≥ 5 years, no gender limitation;\n* Diagnosed with SLE according to the 2019 EULAR\u002FACR classification criteria, and still in moderate to severe disease activity despite ≥ 3 months of high dose glucocorticoids(prednisone≥1mg\u002Fkg\u002Fd or other equivalent amount of other steroid), combined with hydroxychloroquine, and at least 2 Immunosuppressants or biologics (including cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, belimumab, and rituximab) or intolerant to standard treatments;\n* SLEDAI-2K score ≥ 8 points;\n* The functions of vital organs must meet the following requirements:\n\n  1. cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%, with no obvious abnormalities on electrocardiogram (ECG);\n  2. renal function: eGFR ≥ 30 mL\u002Fmin\u002F1.73m2;\n  3. hepatic function: AST and ALT ≤ 3.0×ULN, total bilirubin ≤ 2.0×ULN;\n  4. pulmonary function: no severe pulmonary lesions; blood oxygen saturation ≥ 92% under non-oxygen supplementation conditions.\n* Meet the criteria of leukapheresis or intravenous blood collection, and no contraindication for leukapheresis;\n* Negative pregnancy test for female subjects of childbearing age, and agree to take effective contraceptive measures until one year after infusion;\n* Participant or his\u002Fher guardians agree to participate in the clinical trial and sign the informed consent form indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n* Central nervous system (CNS) diseases: presence of CNS lupus symptoms requiring intervention within 60 days, including epilepsy, confusion, cerebrovascular events, etc;\n* Congenital heart disease or severe arrhythmia before screening: Including multifocal and frequent supraventricular tachycardia, ventricular tachycardia, etc.; or complicated with moderate to large pericardial effusion, severe myocarditis, etc.; or patients with unstable vital signs who require vasopressors to maintain blood pressure;\n* Presence of active infections requiring systemic treatment or uncontrolled infections within 3 months prior to screening;\n* Having received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; or having grade 2 or above acute graft-versus-host disease (GVHD) within 2 weeks prior to screening;\n* Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA level exceeding the normal range; positive for hepatitis C virus (HCV) antibody with peripheral blood hepatitis C virus (HCV) RNA level exceeding the normal range; positive for human immunodeficiency virus (HIV) antibody; positive for treponema pallidum antibody;\n* History of macrophage activation syndrome within 1 month prior to screening (except for those for whom the investigator has determined that safety risks are excluded after treatment);\n* History of previous CAR-T therapy (except for those for whom the investigator has determined that safety risks are excluded after treatment);\n* Presence of active pulmonary tuberculosis at the time of screening;\n* Having received any vaccination within 4 weeks prior to screening;\n* Positive result of blood pregnancy test;\n* A confirmed diagnosis of malignant diseases such as tumors prior to screening;\n* Participation in other clinical trials within 3 months prior to enrollment;\n* Other circumstances that the investigator deems inappropriate for participation in this study.","5 Years",{"count":50,"type":20},[53],"This is an investigator-initiated trial aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.",[83],"Systemic Lupus Erythematosus",[59,58],"2026-02-04",{"date":87,"type":32},"2026-02-11",{"date":89,"type":20},"2026-02",{"date":91,"type":20},"2028-12",{"name":38,"class":39},{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":51,"phases":101,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":70},"100617410","phase-1-study-of-ultra-fast-bcmacd70-car-t-therapy-for-refractory-sle-100617410","NCT07318259","Study of Ultra-Fast BCMA\u002FCD70 CAR-T Therapy for Refractory SLE","Study of Ultra-Fast Autologous BCMA\u002FCD70-Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Age ≥ 18 years old;\n* Diagnosed with SLE according to the 2019 EULAR\u002FACR SLE classification criteria, and still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg\u002Fkg\u002Fd or other equivalent amount of other steriod), and\u002For hydroxychloroquine, and at least 2 DMARDs(include cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, beliumab, and rituximab) or intolerant to standard treatments;\n* SLEDAI-2K score ≥ 8 points;\n* Meet the standards of leukapheresis or intravenous blood collection, and no contraindication for leukapheresis;\n* Negative pregnancy test for female subjects of childbearing age, and agree to take effective contraceptive measures until one year after CAR-T infusion;\n* Participant or his\u002Fher guardians agree to participate in the clinical trial and sign the informed consent form which indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n* Central nervous system (CNS) disease: CNS neurolupus requires intervention within 30 days;\n* Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); or NYHA classification class IV; or combined with moderate to massive pericardial effusion, serious myocarditis, etc; or patient with unstable vital signs who need hypertensive drugs;\n* The functions of important organs meet one of the following conditions: (1)renal function: eGFR\\\u003C30mL\u002Fmin\u002F1.73m2 or require renal replacement therapy; (2)liver function: AST and ALT\\>3.0 ULN, total Bilirubin (TBIL) in serum \\>2.0×ULN; (3)lung function: SpO2\\\u003C92% with no oxygen inhalation;\n* Uncontrollable infection or active infection that requires systemic treatment within 3 months prior to screening;\n* Received hematopoietic stem cell transplantation within 3 months prior to screening, or ≥Grade 2 GVHD within 2 weeks prior to screening;\n* Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; or positive for human immunodeficiency virus (HIV) antibodies; or syphilis test positive;\n* Suffered from active pulmonary tuberculosis at screening;\n* Received live vaccine within 4 weeks prior to screening;\n* Positive in blood pregnancy test;\n* Suffered from malignant disease such as tumors (excluding tumors without active lesions and ending treatment for more than 5 years, as well as fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, thyroid cancer after radical resection, ductal carcinoma in situ after radical resection);\n* Patients who participated in other clinical study within 3 months prior to screening;\n* Any other conditions that the investigators deem it unsuitable for the study.",{"count":50,"type":20},[53],"This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous BCMA\u002FCD70-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.",[83],[105,58],"BCMA\u002FCD70","2026-02-02",{"date":108,"type":32},"2026-02-03",{"date":110,"type":32},"2026-01-26",{"date":112,"type":20},"2028-08",{"name":38,"class":39},{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":51,"phases":121,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":131,"locationsCount":70},"100618426","phase-1-study-of-ultra-fast-cd19-car-t-therapy-for-refractory-sle-100618426","NCT07331467","Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE","Study of Ultra-Fast Autologous CD19-Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Systemic Lupus Erythematosus",{"count":50,"type":20},[53],"This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.",[83],[59,58],"2025-12-28",{"date":127,"type":32},"2026-01-12",{"date":129,"type":20},"2026-01",{"date":112,"type":20},{"name":38,"class":39},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":51,"phases":141,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100584653","phase-1-clinical-trial-of-cd19-targeted-car-t-cell-in-refractory-adult-sle-100584653","NCT06892145","Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE","Phase I Clinical Trial of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) for the Treatment of Refractory Adult Systemic Lupus Erythematosus(SLE)","Inclusion Criteria:\n\n1. The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;\n2. Age ≥ 18 years old , gender not limited;\n3. Patients diagnosed with SLE according to the 2019 EULAR\u002FACR classification criteria,And by hydroxychloroquine, sufficient glucocorticoid (≥1mg\u002Fkg\u002Fd prednisone or equivalent amount of other hormones), to less than 2Treatment with immunosuppressants (including cyclophosphamide, motecophanate, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, etc.), and at least one approved biological agent (including titacept, Beliuzumab, etc.), with a total duration of treatment ≥3 months, still in a disease active state, or unable to tolerate conventional therapy;\n4. SLEDAI-2K score ≥7 points;\n5. Autoantibody test results are positive: ANA antibody positive and\u002For serum anti-DSDNA positive;\n6. Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n   1. Cardiac function: Echocardiography indicates left ventricular ejection fraction ≥ 50%;\n   2. Renal function: serum creatinine ≤ 2.0 × ULN, or creatinine clearance rate ≥ 60ml\u002Fmin (Cockcroft Gault formula);\n   3. Hepatic function: ALT and AST ≤ 3.0 × ULN (may be relaxed to ≤ 3.0 × ULN in cases of combined liver infiltration);\n   4. Total bilirubin ≤ 2.0 × ULN (Gilbert syndrome requires total bilirubin ≤ 3.0 × ULN);\n   5. Pulmonary function: Blood oxygen saturation is ≥ 92% in non oxygen state.\n7. No serious mental disorders;\n8. Meet standards for apheresis or venous blood collection, and no other cell collection contraindications;\n9. Women of childbearing age who have a negative blood pregnancy test and all subjects agree to use reliable and effective contraceptive methods (excluding safe period contraception) for contraception within one year after receiving MC-1-50 cell infusion from the time of signing the informed consent form. Including but not limited to: abstinence, implantable progestogen contraceptives that can inhibit ovulation; Intrauterine device (IUD); Intrauterine hormone release system; Spouse vasectomy; Compound hormone contraceptives that can inhibit ovulation (oral, vaginal, and transdermal); Progesterone contraceptives (oral or injectable) that can inhibit ovulation; When male subjects have sex with fertile women, they must agree to use barrier contraception (such as condom plus spermicidal foam\u002Fgel\u002Ffilm\u002Femulsion\u002Fsuppository). At the same time, participants should commit not to donate eggs (oocytes, oocytes) or sperm for assisted reproduction within one year after cell infusion.\n\nExclusion Criteria:\n\n1. There were severe active central nervous system lupus that required therapeutic intervention at the time of screening;\n2. Acute severe nephritis: had or was undergoing renal replacement therapy within 3 months prior to reinfusion, or had significant renal deterioration that the investigator believed was likely to cause the subject to require high doses of corticosteroids (prednisone ≥1mg\u002Fkg\u002F day or equivalent of other hormones), cyclophosphamide, or mycophanate during the first 3 months of the study;Clinical stable lupus nephritis that can be controlled during screening can be considered;\n3. There were other lupus crises that were not controlled at the time of screening;\n4. Individuals who have received CAR-T therapy or other gene modified cell therapies;\n5. Combined with other autoimmune diseases requiring systemic treatment;\n6. HBsAg or HBcAb positive and HBV DNA test greater than the normal range;HCV antibody positive and HCV RNA detection greater than the normal range;HIV antibody positive;Treponema pallidum antibody positive;\n7. Suffered from any of the following heart diseases:\n\n   1. New York Heart Association (NYHA) stage III or IV congestive heart failure;\n   2. Within the 6 months prior to enrollment, there has been a myocardial infarction, or a coronary artery bypass grafting (CABG) or stent implantation surgery has been performed;\n   3. History of ventricular arrhythmias requiring treatment or unexplained syncope (excluding cases caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n8. Uncontrollable infection in the 1 weeks before enrollment;\n9. History of solid organ transplantation or hematopoietic stem cell transplantation prior to screening；\n10. Cerebrovascular accident or seizure occurred within 6 months prior to screening；\n11. Deep vein or deep artery embolism event within the past 6 months prior to screening;\n12. history of malignant neoplasms (other than tumors with no active lesion and ending treatment \\> 2 years ago, and adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery);\n13. (attenuated) Live vaccine ≤ 4 weeks prior to screening;\n14. Have participated in other clinical trials within one month or five drug half lives (whichever is shorter) before enrollment;\n15. Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving MC-1-50 cell infusion;\n16. Other situations considered by the investigator to be unsuitable to participate in the study.",{"count":140,"type":20},12,[53],"This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the efficacy of MC-1-50 cell preparation in patients with refractory SLE, and to explore the applicable dose regimen for phase II clinical trials.",[144,145],"Systemic Lupus Erythematosus (SLE)","Refractory",[147,83],"CAR T-Cell therapy","2025-12-18",{"date":150,"type":32},"2025-12-22",{"date":152,"type":32},"2025-06-12",{"date":154,"type":20},"2028-02-16",{"name":38,"class":39},2,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":51,"phases":166,"briefSummary":167,"conditions":168,"keywords":172,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":70},"100611341","phase-1-in-vivo-car-t-therapy-for-relapsedrefractory-hematological-malignancies-100611341","NCT07239323","In VIVO CAR-T Therapy for Relapsed\u002FRefractory Hematological Malignancies","Intracellularly Prepared Chimeric Antigen Receptor T-cell Therapy Targeting CD19 for the Treatment of Relapsed\u002FRefractory Hematological Malignancies","Inclusion Criteria:\n\n1. Age ≥ 18 years old, gender unrestricted;\n2. Confirmed diagnosis of relapsed\u002Frefractory malignant hematological tumors, including B-ALL, B-cell lymphoma and multiple myeloma;\n3. ECOG performance status score 0-2, with an expected survival period of ≥ 3 months;\n4. Blood routine test results during the screening period meet the following criteria:\n\n   ① Hemoglobin ≥ 6 g\u002FdL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin (rhEPO) is allowed; for patients meeting the hemoglobin ≥ 6 g\u002FdL criterion, red blood cell transfusion can be used to maintain hemoglobin ≥ 6 g\u002FdL;\n   * Absolute neutrophil count (ANC) ≥ 600\u002FμL (no use of granulocyte colony-stimulating factor \\[G-CSF\\] within 1 week before screening, or no use of pegylated G-CSF within 2 weeks before screening); ③ Platelet count ≥ 50,000\u002FμL; ④ Lymphocyte count ≥ 500\u002FμL;\n5. Normal renal function during the screening period: creatinine clearance rate (CrCl) ≥ 45 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n6. Liver function during the screening period meets the following criteria:\n\n   ① Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3.0 × ULN;\n\n   ② Total bilirubin (TBIL) ≤ 2.0 × ULN (except for congenital hyperbilirubinemia such as Gilbert's syndrome, direct bilirubin can be relaxed to ≤ 1.5 × ULN);\n7. Cardiac function during the screening period meets the following criteria:\n\n   ① Left ventricular ejection fraction (LVEF) ≥ 40% (measured by echocardiography or MUGA scan);\n\n   ② No clinically significant pericardial effusion;\n\n   ③ No clinically significant electrocardiogram (ECG) abnormalities;\n8. Pulmonary function during the screening period meets the following criteria: blood oxygen saturation (SpO₂) ≥ 90%;\n9. Women of childbearing age must have a negative pregnancy test during the screening period and before drug administration, and must not be in the lactation period;\n10. Men and women of childbearing age must agree to take effective contraceptive measures and not donate reproductive cells (including sperm or eggs) from the time of signing the informed consent form until 1 year after the end of study drug administration;\n11. The subject or their legally authorized representative has signed the informed consent form (ICF), indicating their understanding of the purpose and procedures of the study and their voluntary participation in this study.\n\nExclusion Criteria:\n\n1. Other anti-tumor treatments within the screening period (judged by the investigator comprehensively):\n\n   ① Received chemotherapy, targeted therapy or immunotherapy within 5 half-lives before administration;\n\n   ② Received radiotherapy within 4 weeks before administration (if the radiotherapy target area covers ≤ 5% of bone marrow reserve, the time limit for radiotherapy completion is not restricted);\n2. History of hematopoietic stem cell transplantation: Received allogeneic or autologous hematopoietic stem cell transplantation within 3 months before administration;\n3. History of other malignant tumors (except for this disease), except for the following situations:\n\n   ① Received radical treatment and had no known active disease for ≥ 2 years before enrollment;\n\n   ② Had fully treated non-melanoma skin cancer in the past and had no active lesions at present;\n4. Received treatment related to vesicular stomatitis virus glycoprotein (VSVG) pseudotyped virus in the past;\n5. Had severe and uncontrolled infections (bacterial, viral, fungal, etc.) within the screening period;\n6. Clinically significant cardiac diseases:\n\n   * Had symptomatic heart failure or other serious cardiac diseases (such as severe arrhythmia);\n\n     * Had New York Heart Association (NYHA) Class III-IV congestive heart failure; ③ Had a myocardial infarction or received coronary artery bypass grafting (CABG) \u002F coronary artery stent implantation within 6 months before signing the informed consent;\n\n       * Had clinically significant ventricular arrhythmia or a history of unexplained syncope; ⑤ Had a history of syncope (excluding cases caused by vasovagal reactions or dehydration); ⑥ Had a history of severe non-ischemic cardiomyopathy;\n7. Other clinically significant diseases, including but not limited to:\n\n   * Primary immunodeficiency; ② Had a stroke or seizure within 6 months before screening;\n\n     * Had clear clinical evidence of dementia or mental status changes; ④ Had Parkinson's disease, Parkinson-like movement disorders or a history of the above;\n8. Had undergone surgery within 2 weeks before administration, or planned to undergo surgery within 2 weeks after administration (local anesthesia surgery excluded);\n9. Had received live attenuated vaccines within 1 month before administration;\n10. Had a history of severe allergic reactions to this product or its formulation components;\n11. Patients who were not suitable for establishing intravenous access;\n12. The investigator believed that there were other conditions that made the patient unsuitable for participating in this study.",{"count":165,"type":20},24,[53],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory malignant hematological tumors.\n\nIt is an early exploratory clinical study of the safety, tolerability and initial efficacy in the treatment of relapsed or refractory malignant hematological tumors.",[169,170,171],"B-Acute Lymphoblastic Leukemia","B Cell Non-Hodgkin's Lymphoma","Multiple Myeloma",[173,58,174],"in Vivo","malignant hematological tumors","2025-11-16",{"date":177,"type":32},"2025-11-20",{"date":179,"type":32},"2025-07-01",{"date":181,"type":20},"2028-12-31",{"name":38,"class":39},{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":51,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":70},"100606756","phase-1-cea-targeted-car-t-therapy-in-cea-positive-advanced-solid-tumors-100606756","NCT07179692","CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors","Clinical Study of CEA-Targeted Chimeric Antigen Receptor T Lymphocytes (CAR-T) in Advanced CEA-Positive Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years, no gender restriction;\n2. Histopathologically confirmed diagnosis of advanced, metastatic, or recurrent malignant tumors, primarily including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, lung cancer, and cholangiocarcinoma;\n3. Failure of at least second-line standard treatment (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment options;\n4. Immunohistochemical staining of tumor samples showing CEA positivity (clear membrane staining, positivity rate ≥ 10%) within the past 3 months; if the immunohistochemical result is older than 3 months (clear membrane staining, positivity rate ≥ 10%), serum CEA must exceed 10 µg\u002FL;\n5. At least one evaluable lesion according to RECIST 1.1 criteria;\n6. ECOG performance status of 0-2;\n7. Expected survival of ≥ 12 weeks;\n8. No severe psychiatric disorders;\n9. Unless otherwise specified, the following important organ function criteria must be met:\n\n   1. Hematology: White blood cells \\> 2.0 × 10\\^9\u002FL, neutrophils \\> 0.8 × 10\\^9\u002FL, lymphocytes \\> 0.5 × 10\\^9\u002FL, platelets \\> 50 × 10\\^9\u002FL, hemoglobin \\> 90 g\u002FL;\n   2. Cardiac function: Echocardiogram shows ejection fraction ≥ 50%, ECG shows no significant abnormalities;\n   3. Renal function: Serum creatinine ≤ 2.0 × ULN;\n   4. Liver function: ALT and AST ≤ 3.0 × ULN (can be relaxed to ≤ 5.0 × ULN for patients with liver tumor infiltration);\n   5. Total bilirubin ≤ 2.0 × ULN;\n   6. Oxygen saturation \\> 92% without supplemental oxygen;\n10. Eligible for single or venous blood collection, and no contraindications for cell collection;\n11. The subject agrees to use reliable and effective contraception methods from the time of signing the informed consent form until 1 year after CAR-T cell infusion (excluding rhythm method);\n12. The subject or their authorized guardian agrees to participate in this clinical trial and signs the informed consent form (ICF), indicating understanding of the trial's purpose and procedures and willingness to participate in the study.\n\nExclusion Criteria:\n\n1. Clinically symptomatic central nervous system metastasis or meningeal metastasis at screening, or other evidence indicating that central nervous system or meningeal metastasis has not been controlled, as determined by the investigator, making the patient unsuitable for enrollment.\n2. Participation in another clinical trial within 1 month prior to screening.\n3. Receipt of live attenuated vaccines within 4 weeks prior to screening.\n4. Received the following anti-tumor treatments within 14 days or at least 5 half-lives (whichever is shorter) prior to screening: chemotherapy, targeted therapy, or other experimental drug treatments.\n5. Active infection requiring systemic treatment or an uncontrolled infection.\n6. Bowel obstruction, active gastrointestinal bleeding, or a history of major gastrointestinal bleeding within the last 3 months, or severe gastrointestinal conditions such as severe gastric or duodenal ulcers, severe ulcerative colitis, or other severe gastrointestinal inflammations.\n7. Toxicity from prior anti-tumor treatments has not improved to baseline levels or ≤ grade 1, except for alopecia or peripheral neuropathy.\n8. Any of the following cardiac conditions:\n\n   1. New York Heart Association (NYHA) Class III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to enrollment;\n   3. Clinically significant ventricular arrhythmias, or history of unexplained syncope (excluding cases due to vasovagal or dehydration);\n   4. Severe non-ischemic cardiomyopathy.\n9. Active autoimmune diseases or other conditions requiring long-term use of immunosuppressive therapy.\n10. History of another malignancy within the past 3 years, excluding treated and stable in situ cervical cancer or basal cell carcinoma of the skin.\n11. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA levels above the normal range; positive for hepatitis C virus (HCV) antibodies with peripheral blood HCV RNA levels above the normal range; positive for HIV antibodies; or positive for syphilis testing.\n12. Pregnant or breastfeeding women.\n13. Any other conditions that, in the opinion of the investigator, make the patient unsuitable for participation in the study.",{"count":191,"type":20},108,[53],"This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.",[195,196,197,198,199,200],"Lung Cancer","Gastric Cancer","Colon Cancer","Rectal Cancer","Esophageal Cancer","Pancreas Cancer","2025-09-28",{"date":203,"type":32},"2025-10-02",{"date":205,"type":32},"2025-09-12",{"date":207,"type":20},"2028-05-31",{"name":38,"class":39},{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":51,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":228,"leadSponsor":229,"locationsCount":70},"100606912","phase-1-cd70-targeted-car-t-therapy-in-cd70-positive-advanced-solid-tumors-100606912","NCT07181720","CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors","Clinical Study of CD70-Targeted Chimeric Antigen Receptor T Lymphocytes (CAR-T) in Advanced CD70-Positive Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender;\n2. Histologically or cytologically confirmed advanced\u002Fmetastatic solid tumors (tumors with positive CD70 expression, confirmed histopathological ly with IHC 3+ score);\n3. Failed or intolerant to standard second-line treatments (at least one of the following: tyrosine kinase inhibitors (TKIs), poly(ADP-ribose) polymerase inhibitors (PARPi), anti-angiogenic therapy; disease progression or inability to tolerate surgery, chemotherapy, radiotherapy, or targeted therapy);\n4. At least one measurable lesion per RECIST 1.1 criteria, with measurable lesions defined as:\n\n   1. Extranodal lesions with a long axis ≥10mm on CT scan;\n   2. Lymph node lesions with a short axis ≥15mm on CT scan;\n   3. CT slice thickness ≤5mm.\n5. ECOG performance status of 0-2 ;\n6. Expected survival ≥12 weeks;\n7. No history of severe psychiatric disorders;\n8. Adequate organ function as defined by the following:\n\n   1. Hematology: White blood cell count \\>2.0×10⁹\u002FL, neutrophils \\>0.8×10⁹\u002FL, lymphocytes \\>0.5×10⁹\u002FL, platelets \\>50×10⁹\u002FL, hemoglobin \\>90g\u002FL;\n   2. Cardiac: Echocardiogram showing left ventricular ejection fraction (LVEF) ≥50%, and ECG with no significant abnormalities;\n   3. Renal: Serum creatinine ≤2.0×ULN;\n   4. Hepatic: ALT and AST ≤3.0×ULN (may be relaxed to ≤5.0×ULN in cases with liver tumor infiltration); total bilirubin ≤2.0×ULN (may be relaxed to ≤3.0×ULN in cases with Gilbert's syndrome or liver tumor infiltration);\n   5. Oxygen saturation ≥92% without supplemental oxygen;\n9. Ability to undergo single or venous blood collection, with no contraindications to cellular collection;\n10. Female subjects must agree to use reliable contraception (excluding fertility awareness methods) from the time of informed consent until 1 year after CAR-T cell infusion;\n11. Subject or authorized guardian agrees to participate in the trial and signs the informed consent form (ICF), indicating understanding of the trial's purpose and procedures and willingness to participate.\n\nExclusion Criteria:\n\n1. Prior treatment with anti-CD70 therapies;\n2. Active\u002Fsymptomatic central nervous system (CNS) metastasis or meningeal metastasis: Subjects with treated brain metastases are eligible if treatment was completed ≥4 weeks prior to screening and there is no evidence of progression on imaging;\n3. Prior treatments within specified time frames:\n\n   1. Participation in other interventional clinical trials within 3 months before cell infusion (for unapproved drugs, the last dose must be ≥3 months prior; for approved drugs, ≥5 half-lives prior to cell infusion);\n   2. Received chemotherapy or targeted therapy within 2 weeks prior to blood collection or within 5 half-lives of the drug (whichever is shorter);\n   3. Received \\>10mg\u002Fday prednisone (or equivalent) within 2 weeks prior to blood collection, unless for adrenal replacement or inhaled\u002Flocal steroids (except for active autoimmune disease);\n   4. Received live attenuated vaccines within 4 weeks prior to screening;\n4. Active infection requiring systemic treatment or uncontrolled infection within 1 week before screening;\n5. History of any other malignancy within the past 3 years, except for treated and stable non-melanoma skin cancer or malignancies treated with curative intent and no evidence of active disease for ≥3 years;\n6. Cardiovascular conditions:\n\n   1. NYHA Class III or IV heart failure;\n   2. Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to screening;\n   3. Clinically significant ventricular arrhythmias or unexplained syncope (excluding vasovagal or dehydration);\n   4. Severe non-ischemic cardiomyopathy;\n7. Active or uncontrolled autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;\n8. Positive for HBsAg or HBcAb with elevated HBV DNA in peripheral blood; positive for HCV antibodies with detectable HCV RNA levels; positive for HIV antibodies; positive syphilis test;\n9. Toxicity from prior anti-tumor treatments has not resolved to baseline or ≤grade 1, except for alopecia or peripheral neuropathy;\n10. History of venous thromboembolism (e.g., pulmonary embolism) requiring ongoing anticoagulation treatment, or meeting one of the following criteria:\n\n    1. Severe bleeding (grade 3 or 4) lasting for ≥30 days;\n    2. Post-thrombotic sequelae (e.g., persistent dyspnea and hypoxia) due to venous thromboembolism;\n11. Pregnant or breastfeeding women;\n12. Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the trial.",{"count":217,"type":20},90,[53],"This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CD70-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CD70-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CD70-positive advanced malignancies were obtained and the recommended dose and infusion schedule.",[221,195,222,223,224,225],"Renal Cell Carcinoma (RCC)","Anaplastic Thyroid Carcinomas","Ovarian Cancer","Cervical Cancer","Thymic Carcinoma",{"date":203,"type":32},{"date":205,"type":32},{"date":207,"type":20},{"name":38,"class":39},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":51,"phases":239,"briefSummary":240,"conditions":241,"keywords":246,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":70},"100607122","phase-1-clinical-study-of-bcmacd70-targeted-car-t-therapy-for-refractory-pediatric-rheumatic-diseases-100607122","NCT07184450","Clinical Study of BCMA\u002FCD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases","Clinical Study of BCMA\u002FCD70 Targeting Chimeric Antigen Receptor T Lymphocytes(CAR-T) in the Treatment of Refractory Pediatric Rheumatic Diseases","Inclusion Criteria:\n\n* Age ≥5 years old.\n* To meet the diagnostic criteria of refractory B-cell-related pediatric rheumatic diseases, including but not limited to juvenile dermatomyositis, polyarticular juvenile idiopathic arthritis, systemic sclerosis, and primary Sjogren's syndrome.\n\n  1. Diagnosed as juvenile dermatomyositis(JDM) according to the criteria of Bohan and Peter, and meeting the following conditions:\n\n     1. The classification criteria of RJDM must meet (1) and any one of (2)-(5): (1) Patients who are intolerant or unresponsive to glucocorticoids and at least 2 immunosuppressants, and the duration of adequate hormone therapy should be at least 6 months; (2) The disease progresses rapidly and\u002For involves organs such as lungs, heart and gastrointestinal tract; (3) Calcification of subcutaneous or muscle and joint tissues; (4) Repeated rashes or skin ulcers; (5) Repeated or persistent myasthenia(muscle MRI indicates extensive, diffuse edema or the Childhood Myositis Assessment Scale(CMAS) should be less than 48 points, and at least two of the following five core measurement indicators should have abnormal results: Physician Global Assessment(PhGA) ≥2cm, Patient Global Assessment(PtGA) ≥2cm, Disease Activity Score(DAS) ≥2 points, Childhood Health Assessment Questionnaire(C-HAQ) ≥0.25 points, muscle enzyme level \\> 1.5×upper limit of normal);\n     2. RJDM with anti-synthetase syndrome who are positive for anti-synthetase antibody and those with immune-mediated necrotizing myopathy who are positive for SRP or HMGCR antibody can be included.\n  2. Meet the classification criteria for polyarticular juvenile idiopathic arthritis as defined by the International League of Associations for Rheumatology(ILAR) classification in 2001, and meeting the following conditions: After at least 6 months of traditional DMARDS treatment and at least one stable dose of DMARDS or biologic agent for ≥12 weeks, the disease is still active, that is, there are at least 2 active joints (defined as swollen joints; if there is no swelling, there must be limited passive range of motion, accompanied by pain during movement or joint tenderness).\n  3. Meet the classification criteria for Systemic sclerosis (SSc) as defined by the 2013ACR\u002FEULAR standards, and meeting the following conditions:\n\n     1. Meet the definition of intractable disease: Glucocorticoids (≥0.5mg\u002Fkg\u002Fd) and cyclophosphamide, as well as one or more of the following immunomodulators (including antimalarial drugs, azathioprine,mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, beliumab, and telitacicept, etc.), did not show significant remission of the disease for more than 3 months; Or meet the criteria for rapid disease progression , clinical routine treatment is ineffective, and the benefits outweigh the risks as determined by the investigator and the patient's or guardian's full and informed consent can be considered for inclusion;\n     2. Modified Rodnan Skin Score (mRSS) ≥15 points (total 51 points).\n  4. Meet the classification criteria for primary Sjogren's syndrome as defined by the 2002 ACEG classification criteria \u002F2016 EULAR\u002FACR classification criteria, and meeting the following conditions:\n\n     1. Meet (1) and any one of (2)-(6): (1) For those who are intolerant or have an insufficient response to glucocorticoid (prednisone 1-2 mg\u002Fkg\u002Fd or an equivalent dose of other hormones) and at least two immunosuppressants, the duration of hormone treatment should be at least 6 months; (2) The disease progresses rapidly and\u002For involves organs such as the kidneys, nervous system, and lungs; (3) Repeated parotid gland swelling or repeated parotitis; (4) Recurrent rashes or skin ulcers; (5) Involvement of the blood system, repeated leukopenia, anemia or thrombocytopenia; (6) cryoglobulinemia;\n     2. Positive for anti-SSA \u002FRo antibody;\n     3. ESSDAI score ≥5 points or clinESSDAI score ≥5 points.\n* Positive expression of CD19 in peripheral blood B cells determined by flow cytometry, and B cells \\> 5 per\u002FuL.\n* Previously not treated with CAR-T; or recurrence or poor efficacy after previous autologous or universal CD19-targeted CAR-T treatment (evaluated by the researcher).\n* The functions of important organs are basically normal:\n\n  1. Cardiac function: left ventricular ejection fraction (LVEF) ≥55%, no obvious abnormality in electrocardiogram;\n  2. Renal function: eGFR≥30mL\u002Fmin\u002F1.73m2;\n  3. Liver function: AST and ALT≤3.0 ULN, total bilirubin ≤2.0×ULN;\n  4. Lung function: SpO2≥92%.\n* Meet standards for leukapheresis or intravenous blood collection, and no other contraindications for leukapheresis.\n* The subject of childbearing age has a negative urine pregnancy test result and agrees to take effective contraceptive measures during the test period until 1 year after the infusion.\n* The patient or his\u002Fher guardian agrees to participate in this clinical trial and signs an informed consent indicating that he\u002Fshe understands the purpose and procedure of this clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n* Severe major organ involvement related to the primary disease, such as severe pulmonary hypertension (PHA) (mean arterial pressure \\> 45mmHg).\n* primary immunodeficiency or severe secondary immunodeficiency that has not been corrected.\n* accompanied by serious or active or uncontrollable infectious diseases, including but not limited to active tuberculosis, latent tuberculosis infection, active viral hepatitis,etc.\n* Evidence of active malignant disease or diagnosis of malignant tumor(including hematological malignancies and solid tumors, except resected and cured skin basal cell carcinoma).\n* Congenital heart disease or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia,etc.); Or combined with a large number of pericardial effusion, serious myocarditis, etc.;Or patients with unstable vital signs who need hypertensive drugs to maintain their blood pressure.\n* suffering from other diseases that require long-term use of glucocorticoids or immunosuppressants.\n* Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months before screening; Acute graft-versushost disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive.\n* Had received live vaccine within 4 weeks prior to screening.\n* Positive blood pregnancy test.\n* Situations in which other investigators consider it inappropriate to participate in the study.",{"count":238,"type":20},11,[53],"This is an investigator-initiated trial to evaluate the efficacy and safety of BCMA\u002FCD70-targeted CAR-T in the treatment of refractory pediatric rheumatic diseases.",[242,243,244,245],"Juvenile Dermatomyositis (JDM)","Polyarticular Juvenile Idiopathic Arthritis","Systemic Sclerosis (SSc)","Primary Sjogren's Syndrome",[58,105],"2025-09-15",{"date":249,"type":32},"2025-09-19",{"date":251,"type":32},"2025-09-01",{"date":253,"type":20},"2028-09-30",{"name":38,"class":39},{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":51,"phases":264,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":70},"100588755","phase-1-clinical-study-on-chimeric-antigen-receptor-t-lymphocyte-car-t-targeting-cea-for-the-treatment-of-cea---positive-advanced-lung-cancer-100588755","NCT06945523","Clinical Study on Chimeric Antigen Receptor T Lymphocyte (CAR-T) Targeting CEA for the Treatment of CEA - Positive Advanced Lung Cancer","Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) for CEA Positive Advanced Lung Cancer","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender.\n2. Histologically or cytologically confirmed diagnosis of advanced, metastatic, or recurrent lung cancer, including both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).\n3. Disease progression or intolerance following at least one line of prior therapy (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy).\n4. For patients with pleural effusion enrolled in the intrapleural infusion group, accurate assessment of pleural effusion volume and characteristics must be conducted via imaging (chest CT or X-ray) combined with cytological analysis. Cytological examination must confirm the presence of tumor cells in the pleural effusion, indicating malignant pleural effusion.\n5. Positive tumor CEA expression confirmed by immunohistochemistry (IHC) within 3 months prior to screening (defined as clear membranous staining with a positivity rate ≥10%). If IHC testing of tumor samples was performed more than 3 months prior to screening, the patient's serum CEA must be \\>10 ng\u002FmL.\n6. At least one measurable lesion according to RECIST 1.1 criteria: for non-nodal lesions, the longest diameter must be ≥10 mm; for nodal lesions, the short axis must be ≥15 mm.\n7. ECOG performance status score of 0-2.\n8. Expected survival of more than 12 weeks.\n9. No severe psychiatric disorders.\n10. Unless otherwise specified, key organ functions must meet the following requirements:\n\n    1. Hematologic: WBC \\>2.0×10⁹\u002FL, neutrophils \\>1.0×10⁹\u002FL, lymphocytes \\>0.5×10⁹\u002FL, platelets \\>50×10⁹\u002FL, hemoglobin \\>80 g\u002FL;\n    2. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50% by echocardiography, and no significant abnormalities on ECG;\n    3. Renal function: Serum creatinine ≤2.0×ULN;\n    4. Hepatic function: ALT and AST ≤3.0×ULN (≤5.0×ULN if liver metastases are present);\n    5. Total bilirubin ≤2.0×ULN;\n    6. Oxygen saturation (SpO₂) \\>92% on room air.\n11. Eligible for leukapheresis or peripheral venous blood collection and without contraindications for cell collection.\n12. Subjects must agree to use reliable and effective contraception (excluding rhythm method) from the time of informed consent until 1 year after CAR-T cell infusion.\n13. Subject or legally authorized representative must voluntarily sign the informed consent form (ICF), indicating understanding of the study objectives and procedures and willingness to participate in the clinical trial.\n\nExclusion Criteria:\n\n1. Presence of symptomatic central nervous system (CNS) metastases or leptomeningeal metastases at screening, or other evidence indicating that CNS or leptomeningeal lesions are not adequately controlled, making the patient unsuitable for enrollment as judged by the investigator.\n2. Participation in another clinical study within 1 month prior to screening.\n3. Receipt of a live attenuated vaccine within 4 weeks prior to screening.\n4. Prior antitumor therapies before screening including: chemotherapy, targeted therapy, or other investigational drugs administered within 14 days or at least 5 half-lives (whichever is shorter) before screening.\n5. Active or uncontrolled infections requiring systemic treatment.\n6. Tumor compressing the trachea or major blood vessels with high risk as assessed by the investigator.\n7. Presence of any of the following cardiac conditions:\n\n   1. New York Heart Association (NYHA) Class III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to enrollment;\n   3. Clinically significant ventricular arrhythmias or a history of unexplained syncope (excluding vasovagal or dehydration-related causes);\n   4. History of severe non-ischemic cardiomyopathy.\n8. Active autoimmune diseases or other conditions requiring long-term immunosuppressive therapy.\n9. History of other untreated or concurrent malignancies within the past 3 years, except for adequately treated cervical carcinoma in situ or basal cell carcinoma of the skin.\n10. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA levels exceeding the normal range in peripheral blood; positive hepatitis C virus (HCV) antibody with detectable HCV RNA levels exceeding the normal range in peripheral blood; positive for human immunodeficiency virus (HIV) antibodies; or positive syphilis test.\n11. Pregnant or breastfeeding women.\n12. Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in the study.",{"count":263,"type":20},60,[53],"Lung cancer is the leading cause of morbidity and mortality in the world, of which 80%-85% are non-small cell lung cancer (NSCLC). Most patients with NSCLC are at the advanced stage of diagnosis and have a poor prognosis. The 5-year survival rate of stage III patients is about 15%, the 5-year survival rate of stage IV patients is less than 5%, and the median survival time is only 7 months.\n\nCEACAM5 (CEA), also known as CD66e, is a classic tumor marker that has been used as a marker for many types of tumors for 50 years. It is mainly expressed in lung cancer, esophageal cancer, bile duct cancer, colorectal cancer, gastric cancer and other tumor types.\n\nIn previous CAR-T-related clinical trials targeting CEA, the research team found that CAR-T cell preparations had a certain killing effect on CEA positive tumor cells. At the same time, CAR-T cell preparations cannot be sustained for a long time in the body, which is also a key factor restricting the anti-tumor effect of CAR-T cells in the body. To solve this problem, the killing ability and survival ability of CAR-T cell preparations on tumor cells in vitro and in vivo were improved by optimizing CAR structure and improving culture mode.",[267],"Advanced Lung Cancer",[269,58,267],"CEA","2025-05-30",{"date":272,"type":32},"2025-06-04",{"date":274,"type":32},"2025-04-28",{"date":276,"type":20},"2028-04-30",{"name":38,"class":39},{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":260,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":51,"phases":285,"briefSummary":265,"conditions":286,"keywords":287,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":294,"locationsCount":70},"100592373","phase-1-targeted-anti-cea-car-t-immunotherapy-for-advanced-lung-cancer-100592373","NCT06992583","Targeted Anti-CEA CAR-T Immunotherapy for Advanced Lung Cancer","Inclusion Criteria:\n\n\\-\n\nParticipants must meet all of the following criteria to be eligible for enrollment:\n\n1. Age ≥18 years, regardless of gender.\n2. Histologically or cytologically confirmed advanced, metastatic, or recurrent lung cancer, including both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).\n3. Disease progression or intolerance after receiving standard therapies (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy):\n\n   NSCLC: Disease progression or intolerance after at least second-line standard therapy.\n\n   SCLC: Disease progression or intolerance after at least first-line standard therapy.\n4. For patients with pleural effusion assigned to the intrapleural infusion group, the pleural effusion volume and characteristics must be accurately assessed by imaging (chest CT or X-ray) combined with cytology. Malignant pleural effusion must be confirmed by the presence of tumor cells in pleural fluid cytology.\n5. Tumor CEA positivity confirmed by immunohistochemistry (IHC) within 3 months prior to screening, defined as distinct membranous staining with ≥10% positivity. If the tumor sample was assessed more than 3 months prior to screening, a serum CEA level \\>10 µg\u002FL is required.\n6. At least one measurable lesion according to RECIST 1.1 criteria:\n\n   Non-nodal lesions: longest diameter ≥10 mm. Lymph node lesions: short axis ≥15 mm.\n7. ECOG performance status score of 0 to 2 .\n8. Estimated life expectancy of more than 12 weeks.\n9. No severe psychiatric disorders.\n10. Adequate major organ function unless otherwise specified, defined as follows:\n\n    Hematology: WBC \\> 2.0 × 10⁹\u002FL; Neutrophils \\> 1.0 × 10⁹\u002FL; Lymphocytes \\> 0.5 × 10⁹\u002FL; Platelets \\> 50 × 10⁹\u002FL; Hemoglobin \\> 80 g\u002FL.\n\n    Cardiac function: LVEF ≥ 50% on echocardiogram; no significant abnormalities on ECG.\n\n    Renal function: Serum creatinine ≤ 2.0 × ULN. Hepatic function: ALT and AST ≤ 3.0 × ULN (≤ 5.0 × ULN if there is hepatic tumor infiltration).\n\n    Total bilirubin ≤ 2.0 × ULN. Peripheral oxygen saturation \\>92% in room air.\n11. Eligible for leukapheresis or venous blood collection, with no contraindications to cell collection.\n12. Willing to use reliable and effective contraception methods (excluding rhythm method) from informed consent signing until one year after CAR-T cell infusion.\n13. Participant or legally authorized representative has voluntarily signed the informed consent form (ICF), indicating understanding of the study objectives and procedures and willingness to participate in the clinical trial.\n\nExclusion Criteria:\n\n\\-\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n1. Clinically symptomatic central nervous system (CNS) metastasis or meningeal metastasis at screening, or other evidence suggesting the presence of uncontrolled CNS or meningeal metastasis, as judged by the investigator.\n2. Participation in any other clinical trial within 1 month prior to screening.\n3. Vaccination with a live attenuated vaccine within 4 weeks prior to screening.\n4. Receipt of the following anti-tumor treatments within 4 weeks prior to screening: chemotherapy, targeted therapy, or any experimental drug treatment within 14 days or at least 5 half-lives (whichever is shorter).\n5. Active infection requiring systemic treatment or any uncontrolled infection.\n6. Tumor compression of the trachea or major blood vessels, as determined by the investigator to carry a high risk.\n7. History of the following cardiac conditions:\n\n   NYHA Class III or IV congestive heart failure. Myocardial infarction or coronary artery bypass graft (CABG) surgery within 6 months prior to enrollment.\n\n   Clinically significant ventricular arrhythmias or a history of unexplained syncope (except due to vasovagal or dehydration-related causes).\n\n   History of severe non-ischemic cardiomyopathy.\n8. Active autoimmune disease or any condition requiring long-term immunosuppressive therapy.\n9. History of any other untreated malignancy within the past 3 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin.\n10. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA levels above normal range; positive for hepatitis C antibody with peripheral blood HCV RNA levels above normal range; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test.\n11. Pregnancy or breastfeeding women.\n12. Any other condition that the investigator deems unsuitable for participation in the study.",{"count":263,"type":20},[53],[267],[269,58,267],"2025-05-19",{"date":290,"type":32},"2025-05-28",{"date":292,"type":32},"2025-05-08",{"date":276,"type":20},{"name":38,"class":39},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":260,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":51,"phases":302,"briefSummary":265,"conditions":303,"keywords":304,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":70},"100585496","phase-1-anti-cea-car-t-for-advanced-cea-positive-lung-carcinoma-100585496","NCT06903117","Anti-CEA CAR-T for Advanced CEA-Positive Lung Carcinoma","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female;\n2. histologically or pathologically confirmed advanced, metastatic or recurrent lung cancer, including non-small cell lung cancer and small cell lung cancer;\n3. Progression or intolerance (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) after receiving at least second-line standard therapy, patients with driver gene positive non-small cell lung cancer need to receive corresponding targeted therapy for disease progression or intolerance. Patients with driver negative non-small cell lung cancer or small cell lung cancer need to receive platinum-containing chemotherapy for disease progression or intolerance;\n4. Immunohistochemical staining of tumor samples within 3 months confirmed CEA positive (clear membrane staining, positive rate ≥10%); If the immunohistochemical results of tumor samples are more than 3 months from the time of screening (clear membrane staining, positive rate ≥10%), the patient's serum CEA should exceed 10ug\u002FL.\n5. There is at least one evaluable lesion according to RECIST 1.1 criteria, and the length of the extranodal lesion should be ≥10mm; For nodular lesions, the short diameter of the lymph node should be ≥15mm.\n6. ECOG score 0-2 points ;\n7. The expected survival time is more than 12 weeks;\n8. no serious mental disorders;\n9. Unless otherwise stated, the subject's vital organ functions shall meet the following conditions:\n\n   1. Blood routine: Neutrophils\\>1.0×109\u002FL, platelet\\>75×109\u002FL, hemoglobin \\> 80g\u002FL;\n   2. Cardiac function: Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;\n   3. Renal function: serum creatinine ≤2.0×ULN;\n   4. Liver function: ALT and AST≤3.0×ULN (patients with liver tumor infiltration can be relaxed to ≤5.0×ULN);\n   5. Total bilirubin ≤2.0×ULN;\n   6. Blood oxygen saturation in non-oxygen state\\>92%.\n10. Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;\n11. The subject agrees to use a reliable and effective contraceptive method for contraception (excluding safe period contraception) for 1 year from signing the informed consent to receiving the CAR T cell infusion;\n12. The patient or his\u002Fher guardian agrees to participate in the clinical trial and signs the ICF, indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with central nervous system metastasis or meningeal metastasis with clinical symptoms at the time of screening, or with other evidence that the central nervous system metastasis or meningeal metastasis was not controlled, and the investigators judged that they were not suitable for inclusion;\n2. Participating in other clinical studies within 1 month before screening;\n3. Received live attenuated vaccine within 4 weeks prior to screening;\n4. have received any of the following anti-tumor therapies prior to screening: chemotherapy, targeted therapy, or other investigational agents within 14 days or at least 5 half-lives, whichever is shorter;\n5. There is an active infection or uncontrollable infection that requires systemic treatment;\n6. The tumor compresses the trachea or important large blood vessels, and the risk is greater as assessed by researchers;\n7. There is a large number of uncontrollable fluid accumulation in the serous cavity;\n8. Toxicity of previous antitumor therapy has not improved to baseline level or ≤ grade 1, except for alopecia or peripheral neuropathy;\n9. Have any of the following heart conditions:\n\n   1. New York Heart Association (NYHA) Stage III or IV congestive heart failure;\n   2. Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;\n   3. A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n10. Patients with active autoimmune diseases, or other patients requiring long-term immunosuppressive therapy;\n11. Other uncured malignant tumors within the past 3 years or at the same time, except cervical carcinoma in situ and skin basal cell carcinoma;\n12. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA detection greater than the normal range; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis positive;\n13. Women who are pregnant or breastfeeding;\n14. Circumstances deemed unsuitable for participation in the study by other researchers.",{"count":263,"type":20},[53],[267],[269,58],"2025-03-30",{"date":307,"type":32},"2025-04-03",{"date":309,"type":32},"2025-03-24",{"date":311,"type":20},"2028-03-31",{"name":38,"class":39},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":320,"targetDuration":4,"studyType":51,"phases":322,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":339,"leadSponsor":340,"locationsCount":70},"100585984","phase-1-clinical-trial-of-cd5-targeted-car-nk-therapy-for-relapserefractory-t-cell-hematologic-malignancies-100585984","NCT06909474","Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse\u002FRefractory T-Cell Hematologic Malignancies","Clinical Study of CD5 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse\u002FRefractory T-Cell Hematologic Malignancies","Inclusion Criteria:\n\n\\-\n\n1.Gender and Age: No gender restriction; age 18-75 years (inclusive). 2.Diagnosis: Confirmed diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoma, including:\n\n1. T-ALL Patients: Bone marrow morphology during screening shows ≥5% blasts\u002Fimmature lymphocytes and\u002For flow cytometry confirms minimal residual disease (MRD)+, and meets any of the following:\n\n   1. Refractory to ≥2 cycles of standard induction chemotherapy (failure to achieve CR).\n   2. Relapsed within 12 months after achieving CR with first-line induction therapy.\n   3. Failure to achieve CR or relapse after ≥2 lines of chemotherapy.\n   4. Relapse after hematopoietic stem cell transplantation (HSCT).\n2. T-cell Lymphoma Patients: Confirmed diagnosis of T-lymphoblastic lymphoma (T-LBL) or T-cell non-Hodgkin lymphoma (including but not limited to: peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), extranodal NK\u002FT-cell lymphoma (ENKL), T-cell prolymphocytic leukemia (T-PLL), adult T-cell leukemia\u002Flymphoma (ATLL), mycosis fungoides\u002FSézary syndrome (MF\u002FSS) stage IIB or higher), and meets both:\n\n   1. At least one bidimensionally measurable lesion per Lugano 2014 criteria: nodal lesions \\>1.5 cm in long axis; extranodal lesions \\>1.0 cm in long axis.\n   2. Refractory to ≥2 lines of chemotherapy, primary resistance, or relapse post-HSCT.\n\n      3.CD5 Positivity: Confirmed by flow cytometry (≥80% tumor cells express CD5 with mean fluorescence intensity \\[MFI\\] equivalent to normal T cells; Dim defined as MFI ≥1 log lower than normal T cells; partial positivity defined as 20-80% tumor cells expressing CD5) or immunohistochemistry (\\>30% tumor cells express CD5).\n\n      4.ECOG Performance Status: 0-2 . 5.Life Expectancy: ≥12 weeks. 6.Organ Function:\n\n   \u003C!-- -->\n\n   1. Cardiac: Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; no significant ECG abnormalities.\n   2. Renal: Serum creatinine ≤2.0×ULN.\n   3. Hepatic: ALT\u002FAST ≤3.0×ULN (≤5.0×ULN if liver involvement); total bilirubin ≤2.0×ULN.\n   4. Pulmonary: Oxygen saturation ≥92% (room air). 7.No Contraindications: To leukapheresis, venipuncture, or cell collection. 8.No Severe Psychiatric Disorders. 9.Contraception: Agreement to use effective contraception from informed consent until 1 year post-CAR-NK infusion (for patients of childbearing potential).\n\n      10.Informed Consent: Signed by the patient or legal guardian, confirming understanding of the trial's purpose and procedures.\n\nExclusion Criteria:\n\n1. Prior CAR-NK therapy or genetically modified cell therapy.\n2. Active CNS involvement at screening (prior CNS involvement with resolved status post-treatment is allowed).\n3. Recent Anticancer Therapy:\n\n   1. Chemotherapy, targeted therapy, or investigational drugs within 2 weeks or 5 half-lives prior to screening.\n   2. Radiotherapy within 2 weeks prior to screening.\n4. Active\u002FUncontrolled Infection: Within 1 week prior to screening.\n5. Cerebrovascular Event or Seizure: Within 6 months prior to screening.\n6. Viral Infections:\n\n   1. HBV DNA \\> ULN (if HBsAg+ or HBcAb+).\n   2. HCV RNA \\> ULN (if HCV Ab+).\n   3. HIV+, syphilis+, or active tuberculosis.\n7. Cardiac Disease:\n\n   1. NYHA Class III\u002FIV congestive heart failure.\n   2. Myocardial infarction or CABG ≤6 months prior.\n   3. Clinically significant ventricular arrhythmia or unexplained syncope (excluding vasovagal\u002Fdehydration-related).\n   4. Severe cardiomyopathy.\n8. Active\u002FUncontrolled Autoimmune Disease.\n9. Prior Malignancy: Within 5 years, except for cured cervical carcinoma in situ, basal\u002Fsquamous skin cancer, localized prostate cancer, or ductal carcinoma in situ.\n10. Live Vaccination: Within 4 weeks prior to screening.\n11. Pregnancy\u002FLactation: Pregnant, breastfeeding, or planning pregnancy within 1 year post-CAR-NK infusion.\n12. Other: Investigator-determined ineligibility.",{"count":321,"type":20},15,[53],"This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD5 CAR-NK in the treatment of patients with relapsed\u002Frefractory T-Cell hematologic malignancies.",[325],"T-ALL\u002FLymphoma",[327,328,329,330,331,332,333,334,335],"T-ALL","T-LBL","PTCL-NOS","AITL","ALCL","ENKL","T-PLL","ATLL","MF\u002FSS","2025-03-27",{"date":307,"type":32},{"date":336,"type":32},{"date":311,"type":20},{"name":38,"class":39},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":21,"maxAge":48,"enrollmentInfo":348,"targetDuration":4,"studyType":51,"phases":350,"briefSummary":352,"conditions":353,"keywords":355,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":70},"100422500","phase-1-a-clinical-research-of-cd19-and-cd22-targeted-prime-car-t-cell-in-relapsedrefractory-b-all-100422500","NCT04781634","a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed\u002FRefractory B-ALL","Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed\u002FRefractory B-ALL","Inclusion Criteria:\n\n1. Signed written informed consent\n2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:\n\n   1. Failed to standard chemotherapy regimens;\n   2. Relapse after complete remission, high-risk and \u002F or refractory patients ;\n   3. Relapse after hematopoietic stem cell transplantation;\n3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)\n4. Evidence for cell membrane CD19 or CD22 expression\n5. All genders ages: 2 to 75 years\n6. The expect time of survive is above 3 months;\n7. KPS\\>60\n8. No serious mental disorders ;\n9. Left ventricular ejection fraction ≥50%\n10. Sufficient hepatic function defined by ALT\u002FAST≤3 x ULN and bilirubin≤2 x ULN;\n11. Sufficient renal function defined by creatinine clearance≤2 x ULN;\n12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;\n13. With single or venous blood collection standards, and no other cell collection contraindications;\n14. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n\nExclusion Criteria:\n\n1. Previous history of other malignancy;\n2. Presence of uncontrolled active infection;\n3. Evidence of disorder that need the treatment by glucocorticoids;\n4. Active or chronic GVHD\n5. The patients treatment by inhibitor of T cell\n6. Pregnant or breasting-feeding women;\n7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.",{"count":349,"type":20},40,[53,351],"PHASE2","This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed\u002Frefractory B -ALL",[354],"B-ALL",[59,356,58],"CD22","2025-02-23",{"date":359,"type":32},"2025-02-25",{"date":361,"type":32},"2021-03-07",{"date":363,"type":20},"2027-07-01",{"name":38,"class":39},{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":372,"targetDuration":4,"studyType":51,"phases":374,"briefSummary":375,"conditions":376,"keywords":379,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":384,"leadSponsor":385,"locationsCount":70},"100422092","phase-1-a-clinical-research-of-bcma-targeted-prime-car-t-cell-therapy-in-relapsedrefractory-multiple-myeloma-and-plasma-cell-disease-100422092","NCT04776330","a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed\u002FRefractory Multiple Myeloma and Plasma Cell Disease","Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With Relapsed\u002FRefractory Multiple Myeloma and Plasma Cell Disease","Inclusion Criteria:\n\n1. Signed written informed consent;\n2. Diagnose as relapsed \u002Frefractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:\n\n   1. Failed to standard chemotherapy regimens;\n   2. Relapse after complete remission, high-risk and \u002F or refractory patients ;\n   3. Relapse after hematopoietic stem cell transplantation;\n3. Evidence for cell membrane BCMA expression\n4. All genders, ages: 18 to 75 years#\n5. The expect time of survive is above 3 months;\n6. KPS\\>60\n7. No serious mental disorders ;\n8. Left ventricular ejection fraction ≥50%\n9. Sufficient hepatic function defined by ALT\u002FAST≤3 x ULN and bilirubin≤2 x ULN;\n10. Sufficient renal function defined by creatinine clearance≤2 x ULN;\n11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications;\n\n13\\. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n\nExclusion Criteria:\n\n1. Previous history of other malignancy;\n2. Presence of uncontrolled active infection;\n3. Evidence of disorder that need the treatment by glucocorticoids;\n4. Active or chronic GVHD\n5. The patients treatment by inhibitor of T cell\n6. Pregnant or breasting-feeding women;\n7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.",{"count":373,"type":20},80,[53,351],"This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed\u002Frefractory Multiple Myeloma.",[171,377,378],"Neoplasm, Plasma Cell","Multiple Myeloma in Relapse",[171,380,381],"BCMA","prime Chimeric Antigen Receptor T Cell",{"date":359,"type":32},{"date":361,"type":32},{"date":363,"type":20},{"name":38,"class":39},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":392,"targetDuration":4,"studyType":51,"phases":393,"briefSummary":394,"conditions":395,"keywords":396,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":402,"locationsCount":70},"100383360","phase-1-bcma-targeted-car-t-cell-therapy-for-relapsedrefractory-multiple-myeloma-and-plasma-cell-disease-100383360","NCT04271644","BCMA-Targeted CAR-T Cell Therapy for Relapsed\u002FRefractory Multiple Myeloma and Plasma Cell Disease","Inclusion Criteria:\n\n1. Signed written informed consent;\n2. Diagnose as relapsed \u002Frefractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:\n\n   1. Failed to standard chemotherapy regimens;\n   2. Relapse after complete remission, high-risk and \u002F or refractory patients ;\n   3. Relapse after hematopoietic stem cell transplantation;\n3. Evidence for cell membrane BCMA expression；\n4. All genders, ages: 18 to 75 years；\n5. The expect time of survive is above 3 months;\n6. KPS\\>60；\n7. No serious mental disorders ;\n8. Left ventricular ejection fraction ≥50%\n9. Sufficient hepatic function defined by ALT\u002FAST≤3 x ULN and bilirubin≤2 x ULN;\n10. Sufficient renal function defined by creatinine clearance≤2 x ULN;\n11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;\n12. With single or venous blood collection standards, and no other cell collection contraindications;\n13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n\nExclusion Criteria:\n\n1. Previous history of other malignancy;\n2. Presence of uncontrolled active infection;\n3. Evidence of disorder that need the treatment by glucocorticoids;\n4. Active or chronic GVHD；\n5. The patients treatment by inhibitor of T cell；\n6. Pregnant or breasting-feeding women;\n7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.",{"count":373,"type":20},[53,351],"This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed\u002Frefractory Multiple Myeloma.",[171,377,378],[171,380,397],"Chimeric Antigen Receptor T Cell",{"date":359,"type":32},{"date":400,"type":32},"2019-04-01",{"date":363,"type":20},{"name":38,"class":39},{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":260,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":51,"phases":411,"briefSummary":265,"conditions":412,"keywords":413,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":70},"100575120","phase-1-a-clinical-trial-of-cea-targeting-car-t-for-cea-positive-advanced-lung-cancer-100575120","NCT06768151","A Clinical Trial of CEA Targeting CAR-T for CEA Positive Advanced Lung Cancer","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female;\n2. histologically or pathologically confirmed advanced, metastatic or recurrent lung cancer, including non-small cell lung cancer and small cell lung cancer;\n3. Progression or intolerance (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) after receiving at least second-line standard therapy, patients with driver gene positive non-small cell lung cancer need to receive corresponding targeted therapy for disease progression or intolerance. Patients with driver negative non-small cell lung cancer or small cell lung cancer need to receive platinum-containing chemotherapy for disease progression or intolerance;\n4. Immunohistochemical staining of tumor samples within 3 months confirmed CEA positive (clear membrane staining, positive rate ≥10%); If the immunohistochemical results of tumor samples are more than 3 months from the time of screening (clear membrane staining, positive rate ≥10%), the patient's serum CEA should exceed 10ug\u002FL.\n5. There is at least one evaluable lesion according to RECIST 1.1 criteria, and the length of the extranodal lesion should be ≥10mm; For nodular lesions, the short diameter of the lymph node should be ≥15mm.\n6. ECOG score 0-2 points ;\n7. The expected survival time is more than 12 weeks;\n8. no serious mental disorders;\n9. Unless otherwise stated, the subject's vital organ functions shall meet the following conditions:\n\n   1. Blood routine: Neutrophils \\> 1.0×109\u002FL, platelet \\> 75×109\u002FL, hemoglobin \\> 80g\u002FL;\n   2. Cardiac function: Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;\n   3. Renal function: serum creatinine ≤2.0×ULN;\n   4. Liver function: ALT and AST≤3.0×ULN (patients with liver tumor infiltration can be relaxed to ≤5.0×ULN);\n   5. Total bilirubin ≤2.0×ULN;\n   6. Blood oxygen saturation in non-oxygen state \\> 92%.\n10. Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;\n11. The subject agrees to use a reliable and effective contraceptive method for contraception (excluding safe period contraception) for 1 year from signing the informed consent to receiving the CAR T cell infusion;\n12. The patient or his\u002Fher guardian agrees to participate in the clinical trial and signs the ICF, indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with central nervous system metastasis or meningeal metastasis with clinical symptoms at the time of screening, or with other evidence that the central nervous system metastasis or meningeal metastasis was not controlled, and the investigators judged that they were not suitable for inclusion;\n2. Participating in other clinical studies within 1 month before screening;\n3. Received live attenuated vaccine within 4 weeks prior to screening;\n4. have received any of the following anti-tumor therapies prior to screening: chemotherapy, targeted therapy, or other investigational agents within 14 days or at least 5 half-lives, whichever is shorter;\n5. There is an active infection or uncontrollable infection that requires systemic treatment;\n6. The tumor compresses the trachea or important large blood vessels, and the risk is greater as assessed by researchers;\n7. There is a large number of uncontrollable fluid accumulation in the serous cavity;\n8. Toxicity of previous antitumor therapy has not improved to baseline level or ≤ grade 1, except for alopecia or peripheral neuropathy;\n9. Have any of the following heart conditions:\n\n   1. New York Heart Association (NYHA) Stage III or IV congestive heart failure;\n   2. Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;\n   3. A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n10. Patients with active autoimmune diseases, or other patients requiring long-term immunosuppressive therapy;\n11. Other uncured malignant tumors within the past 3 years or at the same time, except cervical carcinoma in situ and skin basal cell carcinoma;\n12. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA detection greater than the normal range; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis positive;\n13. Women who are pregnant or breastfeeding;\n14. Circumstances deemed unsuitable for participation in the study by other researchers.",{"count":410,"type":20},48,[53],[267],[269,58],"2025-01-06",{"date":416,"type":32},"2025-01-10",{"date":418,"type":32},"2024-12-12",{"date":420,"type":20},"2027-12-31",{"name":38,"class":39},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":429,"targetDuration":4,"studyType":51,"phases":431,"briefSummary":432,"conditions":433,"keywords":436,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":450,"leadSponsor":452,"locationsCount":70},"100569175","phase-1-clinical-trial-of-cd123-targeted-car-nk-therapy-for-relapserefractory-aml-or-bpdcn-100569175","NCT06690827","Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse\u002Frefractory AML or BPDCN","Clinical Study of CD123 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse\u002Frefractory Acute Myeloid Leukemia (AML)or Blastic Plasmacytoid Dendritic Cell Neoplasm(BPDCN)","Inclusion Criteria:\n\n1. Patients of any gender, aged between 18 and 75 years (inclusive);\n2. Positive expression of CD123 on tumor cells detected by flow cytometry;\n3. Patients with a confirmed diagnosis of CD123-positive relapsed\u002Frefractory AML or BPDCN:\n\n(1) For AML patients：\n\n* Relapsed refers to the reappearance of leukemic cells in peripheral blood after complete remission (CR), or ≥5% blasts in bone marrow (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy), or the presence of leukemic cell infiltration outside the marrow;\n* Refractory refers to patients who have not responded to two courses of standard treatment; patients who have relapsed within 12 months after CR and consolidation\u002Fintensification therapy; patients who have relapsed after 12 months but have not responded to conventional chemotherapy; patients with two or more relapses; patients with persistent extramedullary leukemia;\n\n  (2) For BPDCN patients: Patients who have not responded to or cannot tolerate the recommended salvage treatment according to guidelines, and have persistent or recurrent disease in any of the following: peripheral blood, bone marrow, lymph nodes, spleen, skin lesions, or other sites.\n\n  4\\. Expected survival time of more than 12 weeks;\n\n  5\\. ECOG score of 0-2 (Appendix 2);\n\n  6\\. No severe mental disorders;\n\n  7\\. Basic normal function of important organs:\n  1. Blood routine: white blood cells \\>1.0×109\u002FL, neutrophils \\>0.5×109\u002FL, lymphocytes \\>0.5×109\u002FL, platelets \\>50×109\u002FL;\n  2. Cardiac function: echocardiography indicates a left ventricular ejection fraction ≥50%, and no significant abnormalities on electrocardiogram;\n  3. Renal function: serum creatinine ≤2.0×ULN;\n  4. Liver function: ALT and AST ≤3.0×ULN (for patients with liver invasion\n\n     * 5.0×ULN);\n  5. Total bilirubin ≤2.0×ULN (for patients with Gilbert's syndrome ≤3.0×ULN);\n  6. Blood oxygen saturation \\>92%. 8. The patient or their legal guardian agrees to participate in this clinical trial and signs the ICF, indicating their understanding of the purpose and procedures of the clinical trial and willingness to participate in the study.\n\nExclusion Criteria:\n\n1. Presence of active central nervous system invasion during screening;\n2. Receipt of anti-tumor therapies prior to screening, including chemotherapy, targeted therapy, or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter), except for those who have confirmed disease progression after treatment;\n3. Occurrence of cerebrovascular accident or epileptic seizure within 6 months prior to screening;\n4. Presence of active or uncontrolled infection requiring systemic treatment within 1 week prior to screening;\n5. Presence of any of the following cardiac diseases:\n\n   1. Congestive heart failure at New York Heart Association (NYHA) class III or IV;\n   2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment;\n   3. Clinically significant ventricular arrhythmia, or history of unexplained syncope (excluding cases caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n6. Combination with active autoimmune diseases requiring long-term immunosuppressive therapy;\n7. Presence of other malignancies, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.\n8. Receipt of live attenuated vaccines within 4 weeks prior to screening;\n9. Pregnant or breastfeeding women, as well as male or female subjects who plan to have children within 1 year after receiving CAR-NK cell infusion;\n10. Other conditions that the investigator deems unsuitable for participation in the study.",{"count":430,"type":20},30,[53],"This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD123 CAR-NK in the treatment of patients with relapsed\u002Frefractory acute myeloid leukemia or blastic plasma cell like dendritic cell tumors.",[434,435],"AML (Acute Myeloid Leukemia)","BPDCN (blastic Plasmacytoid Dendritic Cell Neoplasm)",[437,438,439,440,441,442,443,444,445],"CD123","AML","Acute Myeloid Leukemia","blastic plasmacytoid dendritic cell neoplasm","acute leukemia","Malignant Hematoma","CAR-NK","CD123 CAR-NK","Chimeric antigen natural killer cells","2024-11-13",{"date":448,"type":32},"2024-11-15",{"date":446,"type":20},{"date":451,"type":20},"2028-10-30",{"name":38,"class":39},{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":51,"phases":460,"briefSummary":461,"conditions":462,"keywords":465,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":471,"leadSponsor":473,"locationsCount":70},"100568845","phase-1-clinical-study-of-cd19-targeted-universal-chimeric-antigen-receptor-t-lymphocytes-ucar-t-for-the-treatment-of-refractory-juvenile-dermatomyositis-rjdm-100568845","NCT06686524","Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refractory Juvenile Dermatomyositis (RJDM)","Inclusion Criteria:\n\n* (1) Age ≥ 5 years old;\n* (2) Diagnosis of juvenile dermatomyositis (JDM) according to Bohan and Peter criteria;\n* (3) Meeting the classification criteria for RJDM, and meeting condition ① and any one of ② to ⑤ conditions:\n\n  * Intolerance or inadequate response to glucocorticoids (prednisone 1-2mg\u002Fkg\u002Fd or equivalent dose of other hormones) and at least two immunosuppressants, with hormone therapy lasting for at least 6 months;\n\n    * Rapid progression of the disease and\u002For involvement of organs such as lungs, heart, and gastrointestinal tract;\n\n      * Calcification of subcutaneous or muscular and articular tissues;\n\n        * Repeated skin rashes or ulcers;\n\n          * Repeated or persistent muscle weakness (muscle magnetic resonance imaging indicating widespread, diffuse edema or a Children's Myositis Assessment Scale (CMAS) score \\\u003C 48, and at least two abnormal results among the following five core measurement indicators: Physician's Global Assessment (PhGA) ≥ 2cm, Patient's Global Assessment (PtGA) ≥ 2cm, Disease Activity Score (DAS) ≥ 2 points, Child Health Assessment Questionnaire (C-HAQ) total score ≥ 0.25 points, and muscle enzyme level \\> 1.5 times the upper limit of normal (ULN));\n* (4)Patients with immune-mediated necrotizing myopathy who are positive for SRP or HMGCR antibodies meet the criteria for RJDM and can be directly included;\n* (5) Basic normal function of important organs:\n\n  * Cardiac function: Left ventricular ejection fraction (LVEF) ≥55%, with no significant abnormalities observed in the electrocardiogram;\n\n    * Renal function: eGFR ≥ 30mL\u002Fmin\u002F1.73m2;\n\n      * Liver function: AST and ALT ≤3.0 ULN, total bilirubin ≤2.0×ULN (excluding those caused by primary diseases);\n\n        * Pulmonary function: SpO2 ≥92%;\n* (6) Female subjects of childbearing age have a negative result in the urine pregnancy test and agree to take effective contraceptive measures during the trial until one year after infusion;\n* (7) The patient or their guardian agrees to participate in this clinical trial and signs an informed consent form, indicating their understanding of the purpose and procedures of the clinical trial and their willingness to participate in the study.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will be excluded from this trial:\n\n* (1) Previously received CAR-T cell therapy (except for those whose safety risks have been judged as eliminated by the investigator);\n* (2) Accompanied by primary immunodeficiency disease or severe secondary immunodeficiency disease that has not been corrected;\n* (3) Accompanied by severe, active, or uncontrolled infectious diseases, including but not limited to active tuberculosis, latent tuberculous infection, active viral hepatitis, etc.;\n* (4) Known to have active malignant diseases or confirmed malignancies before screening (including hematological malignancies and solid tumors, except for resected and cured cutaneous basal cell carcinoma);\n* (5) Suffering from congenital heart disease or having a history of acute myocardial infarction within 6 months, or severe arrhythmia (including multifocal frequent ventricular supraventricular tachycardia, ventricular tachycardia, etc.); or complicated with moderate to large pericardial effusion, severe myocarditis, etc.; or unstable vital signs requiring vasopressors to maintain blood pressure;\n* (6) Accompanied by other diseases that require long-term use of glucocorticoids or immunosuppressants;\n* (7) Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months before screening; or presence of acute graft-versus-host disease (GVHD) of grade 2 or above within 2 weeks before screening;\n* (8) Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer detection is greater than the normal reference range; or positive for hepatitis C virus (HCV) antibody and peripheral blood hepatitis C virus (HCV) RNA titer detection is greater than the normal reference range; or positive for human immunodeficiency virus (HIV) antibody; or positive for syphilis test;\n* (9) Received live vaccines within 4 weeks before screening;\n* (10) Positive blood pregnancy test;\n* (11) Participated in other clinical trials within 3 months before enrollment;\n* (12) Other conditions that the investigator considers unsuitable for participation in the study.",{"count":50,"type":20},[53],"This study is an open-label, single-arm, dose-escalation trial primarily designed to evaluate the safety and efficacy of a universal CAR-T cell therapy targeting CD19 in the treatment of patients with RJDM. Additionally, the study aims to characterize its pharmacokinetic and pharmacodynamic properties, explore its role in immune system reconstitution, and assess long-term survival benefits.",[463,464],"Dermatomyositis, Juvenile","Dermatomyositis",[464,59,466,467],"UCAR-T","Universal CAR-T","2024-11-11",{"date":446,"type":32},{"date":468,"type":20},{"date":472,"type":20},"2027-11-10",{"name":38,"class":39},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":51,"phases":482,"briefSummary":483,"conditions":484,"keywords":487,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":70},"100565349","phase-1-clinical-research-of-cd19-targeted-car-t-cell-in-relapsed-refractory-b-all-100565349","NCT06641024","Clinical Research of CD19 Targeted CAR-T Cell in Relapsed\u002F Refractory B-ALL","Phase I Clinical Study of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) for the Treatment of Relapsed\u002FRefractory CD19-positive B-cell Acute Lymphoblastic Leukemia (B-ALL)","Inclusion Criteria:\n\n1. The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;\n2. Age ≥ 18 years old (including threshold), gender not limited;\n3. Diagnosed with B-cell acute lymphoblastic leukemia and meeting one of the following conditions:\n\n   1. Refractory B-ALL: Early refractory patients who have not achieved complete remission of bone marrow after two courses of first-line systemic therapy upon initial diagnosis;\n   2. Relapsed B-ALL:\n\n      ① Early relapsed after complete remission (\\< 12 months);\n\n      ② Late relapsed after complete remission (≥ 12 months) requires systemic therapy again, but if complete remission is not achieved or early treatment response is poor;\n\n      ③ Having experienced 2 or more times bone marrow relapse;\n\n      ④ Relapsed after allogeneic hematopoietic stem cell transplantation;\n   3. Individuals with Philadelphia chromosome positive (Ph+) disease are eligible if they have relapsed\u002Frefractory disease despite treatment with at least 2 different tyrosine kinase inhibitors (TKIs); (Note: Except for those who are intolerant to TKI therapy, or have T315i mutations);\n4. Flow cytometry confirms the expression of CD19 in leukemia cells in the bone marrow. In individuals previously treated with targeted CD19 antibodies (such as blinatumomab), the proportion of CD19 positive cells in leukemia cells must be ≥ 90%;\n5. Morphological disease in the bone marrow (≥ 5% blasts);\n6. ECOG score 0-1;\n7. Expected survival time of more than 12 weeks;\n8. Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n   1. Cardiac function: Echocardiography indicates left ventricular ejection fraction ≥ 50%;\n   2. Renal function: serum creatinine ≤ 2.0 × ULN, or creatinine clearance rate ≥ 60ml\u002Fmin (Cockcroft Gault formula);\n   3. Hepatic function: ALT and AST ≤ 3.0 × ULN (may be relaxed to ≤ 5.0 × ULN in cases of combined liver infiltration);\n   4. Total bilirubin ≤ 2.0 × ULN (Gilbert syndrome requires total bilirubin ≤ 3.0 × ULN);\n   5. Pulmonary function: Blood oxygen saturation is ≥ 92% in non oxygen state.\n9. No serious mental disorders;\n10. Meet standards for apheresis or venous blood collection, and no other cell collection contraindications;\n11. Women of childbearing age who have a negative blood pregnancy test and all subjects agree to use reliable and effective contraceptive methods (excluding safe period contraception) for contraception within one year after receiving MC-1-50 cell infusion from the time of signing the informed consent form. Including but not limited to: abstinence, implantable progestogen contraceptives that can inhibit ovulation; Intrauterine device (IUD); Intrauterine hormone release system; Spouse vasectomy; Compound hormone contraceptives that can inhibit ovulation (oral, vaginal, and transdermal); Progesterone contraceptives (oral or injectable) that can inhibit ovulation; When male subjects have sex with fertile women, they must agree to use barrier contraception (such as condom plus spermicidal foam\u002Fgel\u002Ffilm\u002Femulsion\u002Fsuppository). At the same time, participants should commit not to donate eggs (oocytes, oocytes) or sperm for assisted reproduction within one year after cell infusion.\n\nExclusion Criteria:\n\n1. Isolated extramedullary disease;\n2. Central nervous system abnormalities: defined as CNS-2 and 3 according to NCCN guidelines (note: CNS-2 and 3 can be screened, but must be treated and recovered to CNS-1 before lymphodepleting chemotherapy and infusion);\n3. Transformation of chronic myeloid leukemia to acute biphenotypic leukemia;\n4. Individuals who have received CAR-T therapy or other gene modified cell therapies;\n5. Prior to apheresis, the following anti-tumor treatments have been received: chemotherapy, targeted therapy, and other drug treatments within 14 days or at least 5 half lives (whichever is shorter); Received radiation therapy within 14 days;\n6. HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive; CMV DNA positive;HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive;\n7. Suffered from any of the following heart diseases:\n\n   1. New York Heart Association (NYHA) stage III or IV congestive heart failure;\n   2. Within the 6 months prior to enrollment, there has been a myocardial infarction, or a coronary artery bypass grafting (CABG) or stent implantation surgery has been performed;\n   3. History of ventricular arrhythmias requiring treatment or unexplained syncope (excluding cases caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n8. Uncontrollable infection in the 2 weeks before enrollment;\n9. Acute grade 2-4 graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within the first 4 weeks of enrollment;\n10. If a cerebrovascular accident or seizure occurs within the first 6 months of enrollment;\n11. Active autoimmune diseases;\n12. Deep vein or deep artery embolism event within the past 6 months prior to enrollment;\n13. Poor control of hypertension during screening is defined as systolic blood pressure ≥ 160mmHg and\u002For diastolic blood pressure ≥ 100mmHg (blood pressure values are measured based on the average of three readings taken at least 2 minutes apart. Patients with blood pressure ≥ 160\u002F100mmHg at the initial screening can receive antihypertensive treatment, and if good control is achieved after treatment and blood pressure\\<160\u002F100mmHg, enrollment can be performed);\n14. History of malignancy other than fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery;\n15. (attenuated) Live vaccine ≤ 4 weeks prior to enrollment;\n16. Have participated in other clinical trials within one month or five drug half lives (whichever is shorter) before enrollment;\n17. Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving MC-1-50 cell infusion;\n18. Other situations considered by the investigator to be unsuitable to participate in the study.",{"count":165,"type":20},[53],"This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed\u002Frefractory CD19-positive B Cell Acute Lymphoblastic Leukemia.",[485,486],"Acute Lymphoblastic Leukemia, in Relapse","Refractory Acute Lymphoblastic Leukemia",[354,58],"2024-10-11",{"date":490,"type":32},"2024-10-15",{"date":492,"type":20},"2024-11-01",{"date":494,"type":20},"2039-11-01",{"name":38,"class":39},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":503,"enrollmentInfo":504,"targetDuration":4,"studyType":51,"phases":506,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":70},"100559848","phase-1-clinical-trial-of-cd19-targeted-car-t-therapy-for-refractory-juvenile-dermatomyositis-100559848","NCT06569472","Clinical Trial of CD19-targeted CAR-T Therapy for Refractory Juvenile Dermatomyositis","Clinical Study of CD19 Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Refractory Juvenile Dermatomyositis (RJDM)","Inclusion Criteria:\n\n1. Age: ≥5 years and \\\u003C17 years old\n2. To meet the diagnostic criteria of JDM, four or five of the following criteria must be met:① symmetrical proximal muscle weakness; ②Characteristic skin changes, including positive dermatitis (purplish red rash on upper eyelid with periorbital edema) and Gottron papules (red patchy squamous papules on the back of knuckles); ③ The level of one muscle enzyme in serum was increased; ④ Positive myositis antibody; ⑤Electromyography shows denervation and myopathy; ⑥ Muscle biopsies showed necrosis and inflammation.\n3. The classification criteria of RJDM must meet ① and any of the criteria②-④: ① Patients who are intolerant or unresponsive to glucocorticoids and at least 2 immunosuppressants, adequate hormone therapy and duration of at least 6 months; ② The disease progresses rapidly and\u002For involves organs such as lungs, heart and gastrointestinal tract; ③ Calcification of subcutaneous or muscle and joint tissues; ④ Repeated rashes or skin ulcers.\n4. myositis specific antibody positive, defined as MDA-5, NXP2, TIF-1γ, Ro-52 and any other positive;\n5. If the patient has SRP or HMGCR antibody positive immune-mediated necrotizing myopathy equivalent to RJDM, the inclusion criteria of (2) - (4) can be met.\n6. The functions of important organs are basically normal:\n\n   ① Cardiac function: left ventricular ejection fraction (LVEF) ≥55%, no obvious abnormality in electrocardiogram;\n\n   ② Renal function: eGFR≥30ML\u002Fmin\u002F1.73m2;\n\n   ③ Liver function: AST and ALT≤3.0 ULN, total bilirubin ≤2.0×ULN;\n\n   ④ Lung function: Lung function is basically normal, SpO2≥92%;\n7. Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;\n8. The subject of childbearing age has a negative urine pregnancy test result and agrees to take effective contraceptive measures during the test period until 1 year after the infusion;\n9. The patient or his\u002Fher guardian agrees to participate in this clinical trial and signs an informed consent indicating that he\u002Fshe understands the purpose and procedure of this clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Had previously received CAR T cell therapy;\n2. Have other autoimmune or rheumatic diseases other than JDM;\n3. primary immunodeficiency or severe secondary immunodeficiency that has not been corrected;\n4. accompanied by serious infectious diseases, including but not limited to active tuberculosis, latent tuberculosis infection, active viral hepatitis, etc.;\n5. Evidence of active malignant disease or diagnosis of malignant tumor (including hematological malignancies and solid tumors, except resected and cured skin basal cell carcinoma)\n6. Congenital heart disease or history of acute myocardial infarction within 6 months before screening, or severe arrhythmias (including multi-source frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with a large number of pericardial effusion, serious myocarditis, etc.; Or patients with unstable vital signs who need hypertensive drugs to maintain their blood pressure;\n7. suffering from other diseases that require long-term use of glucocorticoids or immunosuppressants;\n8. There is an active or uncontrollable infection that requires systemic treatment within 1 week prior to screening;\n9. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months before screening; Acute graft-versus-host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening;\n10. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive;\n11. Had received live vaccine within 4 weeks prior to screening;\n12. Positive blood pregnancy test;\n13. Patients with known malignant diseases such as tumors before screening;\n14. Patients who had participated in other clinical trials within 3 months prior to enrollment;\n15. Situations in which other investigators consider it inappropriate to participate in the study.","17 Years",{"count":505,"type":20},10,[53],"This is a Phase I clinical trial to evaluate the efficacy and safety of CD19-targeted CAR-T in the treatment of refractory juvenile dermatomyositis (RJDM).The experiment was divided into two phases: dose exploration (Part A) and dose extension (Part B).",[509],"Juvenile Dermatomyositis",[58,59],"2024-08-23",{"date":513,"type":32},"2024-08-26",{"date":515,"type":32},"2024-07-02",{"date":517,"type":20},"2028-07-31",{"name":38,"class":39},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":51,"phases":527,"briefSummary":193,"conditions":528,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":538},"100516582","phase-1-cea-targeting-chimeric-antigen-receptor-t-lymphocytes-car-t-in-the-treatment-of-cea-positive-advanced-solid-tumors-100516582","NCT06006390","CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors","Chimeric Antigen Receptor T Lymphocytes (CAR-T) Targeting CEA in the Treatment of CEA Positive Clinical Study of Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female;\n2. Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer, esophageal cancer, gastric cancer, and pancreatic cancer;\n3. After receiving at least second-line standard treatment failure (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods;\n4. Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); , the positive rate ≥ 10%), the serum CEA of the patient is required to exceed 10ug\u002FL.\n5. At least one assessable lesion according to RECIST 1.1 criteria;\n6. ECOG score 0-2 points;\n7. No serious mental disorder;\n8. Unless otherwise specified, the function of the vital organs of the subject shall meet the following conditions:\n\n   1. Blood routine: white blood cells\\>3.0×10\\^9\u002FL, neutrophils\\>0.8×10\\^9\u002FL, lymphocytes cells\\>0.5×10\\^9\u002FL, platelets\\>75×10\\^9\u002FL, hemoglobin\\>80g\u002FL;\n   2. Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;\n   3. Renal function: serum creatinine≤2.0×ULN;\n   4. Liver function: ALT and AST ≤3.0×ULN (for patients with liver tumor infiltration, it can be relaxed to ≤5.0×ULN);\n   5. Total bilirubin≤3.0×ULN;\n   6. Oxygen saturation ≥95% in non-oxygen state.\n9. Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;\n10. Subjects agree to use reliable and effective contraceptive methods for contraception within 1 year after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception);\n11. The patients themselves or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.\n\nExclusion Criteria:\n\n1. Those who have central nervous system metastasis or meningeal metastasis at the time of screening are judged by the investigator to be unsuitable for inclusion;\n2. Participated in other clinical studies within 1 month before screening;\n3. vaccinated with live attenuated vaccine within 4 weeks before screening;\n4. Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);\n5. Active infection or uncontrollable infection requiring systemic treatment;\n6. Patients with intestinal obstruction, active gastrointestinal bleeding, or a history of gastrointestinal bleeding within 3 months;\n7. Except for alopecia or peripheral neuropathy, the toxicity of previous anti-tumor therapy has not improved to the baseline level or ≤ grade 1;\n8. Suffering from any of the following heart diseases:\n\n   1. New York Heart Association (NYHA) stage III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;\n   3. Clinically significant ventricular arrhythmia, or a history of unexplained syncope (except those caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n9. Patients with active autoimmune disease, or other patients requiring long-term immunosuppressive therapy;\n10. Suffering from other uncured malignant tumors in the past 3 years or at the same time, except cervical carcinoma in situ and basal cell carcinoma of the skin;\n11. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer test is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;\n12. Women who are pregnant or breastfeeding;\n13. Other investigators deem it unsuitable to participate in the research.",{"count":263,"type":20},[53,351],[196,197,198,199,200,195,529],"Breast Cancer","2024-08-06",{"date":532,"type":32},"2024-08-09",{"date":534,"type":32},"2023-09-07",{"date":536,"type":20},"2026-08-31",{"name":38,"class":39},3,{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":546,"maxAge":547,"enrollmentInfo":548,"targetDuration":4,"studyType":51,"phases":550,"briefSummary":551,"conditions":552,"keywords":555,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":562,"locationsCount":505},"100464986","phase-2-a-study-of-pcar-19b-in-the-treatment-of-cd19-positive-relapsedrefractory-b-all-in-children-and-adolescents-100464986","NCT05334823","A Study of pCAR-19B in the Treatment of CD19-positive Relapsed\u002FRefractory B-ALL in Children and Adolescents","A Phase II Clinical Study of Anti-CD19 CAR-T Therapy (pCAR-19B) in the Treatment of CD19-positive Relapsed\u002FRefractory B-ALL","Inclusion Criteria:\n\n1. The patient himself or his guardian agrees to participate in this clinical trial and signs the Informed Consent Form (ICF), indicating that he understands the purpose and procedures of this clinical trial and is willing to participate in the research;\n2. Diagnosed with B-ALL，and meet one of the following conditions:\n\n   1. Refractory B-ALL: early-stage refractory patients who failed to achieve complete remission after 2 courses of standard induction chemotherapy;\n   2. Relapsed B-ALL: patients with early relapse (\\\u003C12 months) after complete remission;or late relapse (≥12 months) after complete remission, and relapsed patients who have not achieved complete remission after standard treatment or have poor response to early treatment; experience Patients with 2 or more bone marrow recurrences; patients with recurrence after allogeneic hematopoietic stem cell transplantation;\n   3. For Ph+ALL patients, patients who have not achieved complete remission after receiving at least two Tyrosine kinase inhibitors (TKI) treatments or have relapsed after complete remission (except those who cannot tolerate TKI treatment or have contraindications to TKI treatment or have T315i mutation resistance to TKI drugs);\n3. The malignant cells in the bone marrow were confirmed to express CD19 by flow cytometry;\n4. Bone marrow morphology at the time of screening indicated that blasts≥ 5%;\n5. Eastern Cooperative Oncology Group (ECOG) 0-1 points ;\n6. Expected survival is ≥ 12 weeks;\n7. The function of important organs is basically normal:\n\n   1. Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;\n   2. Renal function: serum creatinine≤2.0×ULN;\n   3. Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤5.0×ULN;\n   4. Total bilirubin≤2.0×ULN (for Gilbert syndrome, total bilirubin≤3.0×ULN);\n   5. Blood oxygen saturation≥92% in non-oxygen state.\n8. No serious mental disorder;\n9. Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;\n10. Subjects of childbearing age agree to use reliable and effective contraceptive methods for contraception (excluding rhythm contraception) from signing the informed consent to receiving pCAR-19B cell infusion within 1 year.\n\nExclusion Criteria:\n\n1. Relapse of isolated extramedullary disease;\n2. Active central nervous system leukemia at screening, defined as Central Nervous System (CNS)-grade 2 and 3 according to National Comprehensive Cancer Network (NCCN) guidelines (note: those with central nervous system involvement but improved after treatment can be included);\n3. Those who have received CAR-T therapy or other gene-modified cell therapy before screening;\n4. Received anti-CD19 drug treatment before screening;\n5. Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy and other drug treatments within 14 days or at least 5 half-lives (whichever is shorter); Received radiotherapy within 14 days;\n6. HBsAg or HBcAb positive and hepatitis B virus (HBV) DNA is greater than the normal range; hepatitis C virus (HCV) antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive; Cytomegalovirus (CMV) DNA positive;\n7. Have any of the following heart conditions:\n\n   1. New York Heart Association (NYHA) stage III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass grafting within 6 months prior to enrollment (CABG);\n   3. Clinically significant ventricular arrhythmia, or history of syncope of unknown origin (by vasovagal except those caused by menstruation or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n8. Active infection or uncontrollable infection requiring systemic treatment within 1 week before screening;\n9. The presence of grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening;\n10. Cerebrovascular accident or epileptic seizure within 6 months before screening;\n11. Active autoimmune diseases；\n12. Patients with malignant tumors other than acute lymphoblastic leukemia within 5 years before screening, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and duct in situ after radical resection cancer;\n13. Received live attenuated vaccine within 4 weeks before screening;\n14. Participated in other interventional clinical studies before screening, including: the last use of unmarketed new drugs is less than 3 months from the time of cell reinfusion, or the last use of marketed drugs is less than 5 half-lives from the time of cell reinfusion;\n15. Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving pCAR-19B cell reinfusion;\n16. Other investigators deem it inappropriate to participate in the study.","3 Years","21 Years",{"count":549,"type":20},100,[351],"This is a phase II clinical study to evaluate the safety and efficacy of pCAR-19 B cell autologous infusion preparation in the treatment of CD19-positive relapsed\u002Frefractory B-cell acute lymphoblastic leukemia.",[553,554,486],"Acute Lymphoblastic Leukemia","Relapsed Pediatric ALL",[58,59,354],"2024-07-30",{"date":558,"type":32},"2024-07-31",{"date":560,"type":32},"2022-01-26",{"date":179,"type":20},{"name":38,"class":39},{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":51,"phases":572,"briefSummary":573,"conditions":574,"keywords":579,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":587,"locationsCount":70},"100532680","phase-1-a-clinical-research-about-cd70-targeted-car-t-in-the-treatment-of-cd70-positive-advancedmetastatic-gynecologic-cancer-100532680","NCT06215950","A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced\u002FMetastatic Gynecologic Cancer","A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced\u002FMetastatic Gynecologic Cancer","Inclusion Criteria:\n\n1. Age ≥18 years old;\n2. Advanced\u002Fmetastatic gynecological tumor confirmed by histopathology or cytology (paraffin sections or fresh biopsy tumor tissue specimens) (CD70 positive tumor expression (CD70 positive tumor confirmed by histology or pathology (IHC 3+));\n3. Failure or intolerance after standard treatment (disease progression or intolerance such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.), and currently no effective treatment;\n4. According to the RECIST version 1.1 standard, there is at least one measurable diameter and evaluable target lesion. Measurable lesions are defined as: extranodal lesions with CT scan diameter ≥10mm, lymph node lesions with CT scan diameter ≥15mm, scan layer thickness ≤ 5mm, and have not received local treatment;\n5. ECOG 0 \\~ 2 points ;\n6. Expected survival time is more than 12 weeks;\n7. No serious mental disorders;\n8. The functions of important organs are basically normal:\n\n   1. Hematopoietic function: neutral granules \\>1.0×109\u002FL, platelet \\>75×109\u002FL, hemoglobin \\>80g\u002FL;\n   2. Cardiac function: Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;\n   3. Renal function: serum creatinine ≤2.0×ULN;\n   4. Liver function: ALT and AST ≤2.0×ULN (patients with liver tumor infiltration can be relaxed to ≤3.0×ULN);\n   5. Total bilirubin ≤2.0×ULN (Gilbert syndrome or liver tumor infiltration can be relaxed to ≤3.0×ULN);\n   6. Blood oxygen saturation in non-oxygen state\\>92%.\n9. Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;\n10. The subject agrees to use a reliable and effective contraceptive method for contraception (excluding safe period contraception) within 1 year from signing the informed consent to receiving the CAR T cell infusion;\n11. The subject or his\u002Fher guardian agrees to participate in the clinical trial and signs the ICF, indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Received anti-CD70 drug therapy before screening;\n2. Active\u002Fsymptomatic central nervous system metastasis or meningeal metastasis at the time of screening; Treated subjects with brain metastases can only be enrolled if no radiographically demonstrated progression is demonstrated ≥4 weeks after the end of treatment.\n3. Received any of the following treatments prior to screening:\n\n   1. Participated in other interventional clinical studies before screening, including: the time of last use of unmarketed new drugs less than 3 months from cell transfusion, or the time of last use of marketed drugs less than 5 half-lives from cell transfusion;\n   2. Received anti-tumor therapy such as chemotherapy or targeted therapy within 2 weeks of preapheresis or at least 5 half-lives (whichever is shorter); Received systemic radiation within 4 weeks and local radiation within 2 weeks; Or received radioactive drugs (strontium, samarium) within 8 weeks prior to treatment.\n   3. Systemic corticosteroid therapy with doses greater than 10mg\u002F day of prednisone (or equivalent doses of other corticosteroids) within 2 weeks of preapheresis (in the absence of active autoimmune disease, inhaled or topical steroid use and adrenocortical replacement with doses greater than 10mg\u002F day of prednisone efficacy dose are permitted);\n   4. Received live attenuated vaccine within 4 weeks prior to screening;\n4. There is an active or uncontrolled infection requiring systemic treatment within 1 week prior to screening;\n5. Had malignancies other than the target tumor within 3 years prior to screening, except for malignancies that had received radical treatment and had no known active disease for ≥3 years prior to enrollment; Or adequately treated non-melanoma skin cancer with no evidence of disease;\n6. Have any of the following heart conditions:\n\n   1. New York Heart Association (NYHA) Stage III or IV congestive heart failure;\n   2. Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;\n   3. A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy.\n7. Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.\n8. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal range; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis positive; Cytomegalovirus (CMV) DNA test positive;\n9. The subject has a history of venous embolism (e.g., pulmonary embolism) and currently requires anticoagulant therapy, or if: a. Bleeding with grade 3 to 4 persists for more than 30 days; b. have sequelae from venous embolism (e.g. persistent dyspnea and hypoxia); (Note: Participants who have venous embolism but do not meet the above criteria can participate in the test);\n10. Poorly controlled hypertension, defined as systolic blood pressure ≥150mmHg and\u002For diastolic blood pressure ≥90mmHg (Blood pressure values are measured based on the average of 3 readings at least 2 minutes apart, patients with blood pressure ≥150\u002F90 MMHG at initial screening may receive antihypertensive treatment, if well controlled after treatment, And blood pressure \\\u003C 150\u002F90mmHg can be screened);\n11. Women who are pregnant or breastfeeding, and male or female subjects who plan to have a family within 1 year after receiving CAR T cell transfusion;\n12. Conditions deemed unsuitable for participation in the study by other researchers.",{"count":571,"type":20},36,[53],"This is a single-center, double-arm, open-label study. this study plans to evaluate the safety and efficacy of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced\u002Fmetastatic Gynecologic Cancer, and obtain recommended doses and infusion patterns.",[223,575,576,577,578],"Cervix Cancer","Metastatic Cancer","Advanced Cancer","Gynecologic Cancer",[58,580],"CD70","2024-01-11",{"date":583,"type":32},"2024-01-22",{"date":585,"type":32},"2024-01-10",{"date":420,"type":20},{"name":38,"class":39},""]