[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Juventas Cell Therapy Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":240},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,45,67,92,119,139,158,180,201,221],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100614141","early-phase-1-a-study-of-cnct19-in-the-treatment-of-relapsed-or-refractory-neurological-autoimmune-diseases-100614141",false,"NCT07275736","A Study of CNCT19 in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases","An Exploratory Clinical Study on the Safety and Efficacy of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Autoimmune Neurological Diseases","Inclusion Criteria:\n\n1. Patients who are willing to sign the informed consent form;\n2. Aged 18-75 years, male or female;\n3. At screening, subjects with relapsed\u002Frefractory antibody-mediated inflammatory neurological diseases without effective treatment, the expression of CD19+ B cells in peripheral blood and meeting the special criteria for different indications include:\n\n   * Neuromyelitis optica spectrum disorder (NMOSD): Comply with the diagnostic criteria for NMOSD of the International panel for NMO diagnosis (IPND) in 2015 and meet the following requirements:\n\n     1. aquaporin 4 (AQP4) -IgG positive\n     2. At least one immunosuppressant has been used for more than one year and the symptoms have not been well controlled;\n     3. EDSS score ≤8 points;\n     4. There must be at least two relapses within 24 months prior to screening or at least one relapse within the past 12 months, and the relapses should be stable for at least 4 weeks.\n   * Myasthenia gravis (MG): MG subjects who meet the MGFA classification II-IV as defined by the 2020 American Myasthenia Gravis Foundation (MGFA) diagnostic criteria and satisfy the following requirements:\n\n     1. AChR-Ab serum positive or MuSK antibody positive;\n     2. The MG-ADL score is ≥6 points, and the eye muscle score is less than 50% of the total score;\n     3. There is one of the following poor control conditions in the previous treatment: i. After at least two conventional immunotherapy drugs (including hormone and non-hormone immunosuppressants) have been used for ≥1 year without treatment failure, that is, despite receiving IST treatment, ADL remains persistently impaired (persistent weakness, crisis or inability to tolerate IST); ii. At least one IST treatment has failed, and long-term PE or IVIg treatment is required to control symptoms, that is, PE or IVIg treatment for muscle weakness needs to be carried out regularly for at least two cycles in the past 12 months.\n   * Chronic inflammatory demyelinating polyradiculopathy (CIDP): Meet the 2021 EAN\u002FPNS diagnostic criteria (progressive or recurrent type), and have a corrected INCAT disability scale total score of 2-9 (with 2 points coming from leg disability), and meet the following requirements:\n\n     1. Standardized use of at least one first-line therapy (cortisol hormone therapy, γ -globulin or plasma exchange therapy) for more than 3 months with poor symptom control;\n     2. Inability to tolerate cortisol hormone, gamma globulin and plasma exchange due to side effects or other circumstances;\n     3. Determined as an active disease (CIDP disease activity status \\[CDAS\\] score ≥2), (the disease must show activity and present clinically significant deterioration on at least one CIDP clinical assessment tool (including INCAT, I-RODS or mean grip strength)\n   * Multiple Sclerosis (MS): According to the revised McDonald diagnostic criteria in 2017, a clinical diagnosis of MS is made, and the following three points are simultaneously met:\n\n     a) Before ICF and in any of the following circumstances: i. Two relapses have been recorded in the past two years. ii. One recurrence was recorded within the past year. iii. The result of Gd enhanced MRI scan was positive within one year before screening. Note: If there is no positive result of Gd enhanced scan recorded in the previous year, the screening MRI scan results can be used.\n\n     b) Neurological stability within one month before screening and baseline (including no recurrence of MS at this stage)\n   * Autoimmune encephalitis (AE): According to the 2016 International Diagnostic Criteria for Autoimmune Encephalitis, the subject was diagnosed with autoimmune encephalitis and met all of the following requirements:\n\n     1. At least one pathogenic antibody, NMDAR or LGI1, is positive;\n     2. Previously standardized use of corticosteroids, at least one immunosuppressant\u002Fmodulator, including CD20 monoclonal antibodies with poor symptom control or intolerance;\n     3. Autoimmune encephalitis occurred within 3 months before screening;\n     4. Modified Rankin Scale (mRS) score ≥2 or Clinical Assessment Scale for Autoimmune Encephalitis (CASE) score ≥4.\n   * Anti-myelin oligodendrocyte glycoprotein immunoglobulin G antibody-related disease (MOGAD): Comply with the diagnostic criteria released by the International MOGAD Expert Group in 2023 and meet all of the following requirements:\n\n     1. Serum positive for anti-MOG antibodies\n     2. There was a history of ≥1 recurrence of MOGAD within 12 months prior to screening, or ≥2 episodes within 24 months prior to screening.\n4. Proper organ function, complying with the following criteria :\n\n   * Blood routine: Absolute lymphocyte count (ALC) ≥0.4×109\u002FL, platelet count (PLT) ≥50×109\u002FL, hemoglobin ≥80 g\u002FL;\n   * Coagulation function: International Normalized ratio (INR) ≤1.5 times the upper limit of normal (ULN), and activated partial prothrombin time (APTT) ≤1.5 times ULN;\n   * Liver function: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN, total bilirubin ≤1.5 times ULN;\n   * Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance rate (Cockcroft Gault formula) ≥60 mL\u002Fmin;\n   * Pulmonary function: Under indoor ventilation conditions, the blood oxygen saturation in the non-oxygen inhalation state is ≥92%; There is no clinically significant pleural effusion.\n5. The clinical physician evaluated the patient's condition and allowed the use of glucocorticoids at a dose not exceeding 10mg of prednisone or its equivalent during the study period, and permitted the discontinuation of all immunosuppressants.\n6. The subjects whose partners are fertile agree to use effective contraceptive measures throughout the treatment period and for 24 months after the treatment, and during this period, they are not allowed to donate eggs\u002Fsperm for assisted reproduction. Female subjects of childbearing age (women who have undergone sterilization surgery or have been menopausal for ≥12 months are not considered fertile) have negative urine pregnancy or blood pregnancy tests during the screening period.\n\nExclusion Criteria:\n\n1. Current medical conditions or neurological disorders that may affect the effectiveness assessment, such as dementia, schizophrenia, bipolar disorder, major depressive disorder, history of multiple traumatic brain injury, current alcohol\u002Fdrug abuse or dependence, or alcohol\u002Fdrug dependence within the past two years.\n2. Pregnancy or breastfeeding;\n3. Have received organ or hematopoietic stem cell transplantation in the past;\n4. There has been a history of new thrombosis or organ infarction within the past six months;\n5. Patients diagnosed with active connective tissue diseases and requiring non-hormonal immunosuppressants\u002Fmodulators for treatment;\n6. Combined with active infections (such as sepsis, bacteremia, mycosis, uncontrolled pulmonary infection and active tuberculosis, etc.);\n7. Positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis Be antigen (HBeAg); Positive hepatitis Be antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab), and HBV-DNA copy number greater than the measurable lower limit; Positive for hepatitis C (HCV) antibody Positive for human immunodeficiency virus (HIV) antibody; Those who test positive for syphilis (TP); The copy numbers of EBV-DNA and CMV-DNA are greater than the measurable lower limit.\n8. Having undergone major surgery that was evaluated by the researcher as unsuitable for inclusion within 4 weeks prior to screening;\n9. Other malignant tumors that have occurred or are currently present within the five years prior to screening are excluded, except for those with negligible risk of metastasis or death and curable tumors, such as well-treated cervical carcinoma in situ and basal cell carcinoma of the skin.\n10. The patient's heart meets any of the following conditions:\n\n    * Left ventricular ejection fraction (LVEF) ≤45%;\n    * Persistent hypertension (≥160\u002F100 MMHG) that remains uncontrolled despite standardized treatment\n    * New York Heart Association (NYHA) Grade III or IV congestive heart failure or active heart disease;\n    * Severe arrhythmias requiring treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia);\n    * The QTcB interval is ≥450ms for males and ≥470ms for females (QTcB=QT\u002FRR1\u002F2);\n    * Had myocardial infarction, bypass surgery or stent surgery within 6 months prior to the study;\n    * Other heart diseases that the researcher judged as unsuitable for enrollment;\n11. Have received a live vaccine within 6 weeks before screening.\n12. Participate in other interventional clinical studies before cell reinfusion,or receiving treatment of an active investigational drug within 5 half-lives . Those who have received active trial drug treatment, or who intend to participate in another clinical trial or receive treatment other than that stipulated in the protocol throughout the study period.\n13. Those who are known to have hypersensitivity reactions to the components of the preparations used in the test;\n14. Previously received CAR-T cell therapy;\n15. Other conditions that the investigator considers unsuitable for participation in the study.","ALL","18 Years","75 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This study is a single-arm, open-label, non-randomized clinical trial aimed at evaluating the safety, tolerability and preliminary efficacy of CNCT19 cell injection in the treatment of patients with relapsed\u002Frefractory Neurological Autoimmune Diseases.",[27],"Neurological Autoimmune Diseases",[29,30,31],"CAR-T","CNCT19","neurological autoimmune diseases","RECRUITING","2026-03-03",{"date":35,"type":36},"2026-03-05","ACTUAL",{"date":38,"type":36},"2025-03-01",{"date":40,"type":21},"2029-06-01",{"name":42,"class":43},"Juventas Cell Therapy Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100613332","early-phase-1-a-study-of-hy001n-in-the-treatment-of-relapsed-or-refractory-neurological-autoimmune-diseases-100613332","NCT07265206","A Study of HY001N in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases","An Exploratory Clinical Study on the Safety and Efficacy of HY001N Cell Injection in the Treatment of Relapsed or Refractory Autoimmune Neurological Diseases",{"count":52,"type":21},15,[24],"This study is a single-arm, open-label, non-randomized clinical trial aimed at evaluating the safety, tolerability and preliminary efficacy of HY001N cell injection in the treatment of patients with relapsed\u002Frefractory Neurological Autoimmune Diseases.",[27],[29,57,31],"HY001N","NOT_YET_RECRUITING","2025-12-02",{"date":61,"type":36},"2025-12-04",{"date":63,"type":21},"2025-12-30",{"date":65,"type":21},"2028-12-30",{"name":42,"class":43},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100599967","phase-1-inaticabtagene-autoleucel-injection-in-the-treatment-of-autoimmune-hemolytic-anemia-after-three-or-more-lines-of-therapy-100599967","NCT07091370","Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia After Three or More Lines of Therapy","A Multicenter, Open-label, Single-arm Phase I Clinical Trial on the Safety and Tolerability of Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia That Has Failed at Least Three Lines of Treatment","Inclusion Criteria:\n\n1. Age range: 18-75 years (including 18 and 75 years), regardless of gender.\n2. Clinically diagnosed with AIHA or Evans, with hemoglobin lower than 100g\u002FL and symptoms related to anemia according to the diagnostic criteria of the \"Diagnosis and Treatment Guidelines for Autoimmune Hemolytic Anemia in Chinese Adults (2023 Edition)\" and the \"Chinese Expert Consensus on the Diagnosis and Treatment of Evans Syndrome (2024 Edition)\". And meet the diagnostic criteria of failure in at least three lines of treatment as follows:\n\n   Patients diagnosed with warm resistance type AIHA (wAIHA)\u002Fmixed AIHA (mAIHA) \u002FEvans syndrome, the following conditions must be met: first-line glucocorticoid treatment failed, second-line rituximab treatment failed and failure of third-line treatment measures (including any one or more of splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, fludarabine, bortezomib, etc.) Patients diagnosed with cold-resistant type AIHA (cAIHA), that is, cold agglutinin disease (CAD), the following conditions must be met: first-line rituximab treatment failed, second-line rituximab ± bendamustine\u002Ffludarabine failed and failure of third-line treatment measures (including any one or more of bortezomib, cyclosporine, cyclophosphamide, mycophenolate mofetil, azathioprine, etc.)\n3. Women of childbearing potential must have a negative blood pregnancy test during the screening period. Any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least 2 year following infusion of CAR-T cells. Childbearing potential is biologically capable of bearing a living baby and sexually active. Female patients who were not of childbearing potential (ie, met at least 1 of the following criteria):\n\n   Hysterectomy or oophorectomy, or medically confirmed ovarian failure, or medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months in the absence of pathological or physiological causes).\n4. Adequate organ function according to the following criteria:\n\n   Aspartate aminotransferase (AST) ≤ 3 times of upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 times ULN; Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft and Gault formula); International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 times the ULN; Must have minimal pulmonary reserve and oxygen saturation \\> 93% in a nonoxygenated state;\n5. The Eastern Cancer Consortium (ECOG) performance status score is 0-2.\n\nExclusion Criteria:\n\n1. Previously diagnosed proliferative tumors of the lymphatic system;\n2. Secondary AIHA caused by drugs or infections;\n3. Pregnancy or breastfeeding;\n4. Previously undergone organ or hematopoietic stem cell transplantation;\n5. A history of new thrombosis or organ infarction within 6 months prior to screening;\n6. The active stage diagnosed as a connective tissue disease;\n7. Suffering from hereditary hemolytic diseases or other acquired hemolytic diseases;\n8. Combined with active infections (such as sepsis, bacteremia, mycosis, uncontrolled pulmonary infection and active tuberculosis, etc.);\n9. Positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis Be antigen (HBeAg); Hepatitis Be antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab) are positive, and the HBV-DNA copy number is greater than the measurable lower limit; Positive for hepatitis C (HCV) antibody; Positive for human immunodeficiency virus (HIV) antibody; Those with positive syphilis (TP) test;\n10. Major surgery that was assessed as unsuitable by the investigators within 4 weeks before screening;\n11. Patients with concurrent active malignancy within the past five years, those with a history of malignancy but cuired are eligible.\n12. The patient's heart meets any of the following conditions:\n\n    * Left ventricular ejection fraction (LVEF) ≤45%;\n    * New York Heart Association (NYHA) grade III or IV congestive heart failure or active heart disease;\n    * Severe arrhythmias requiring treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia);\n    * The QTcB interval was ≥450ms for males and ≥470ms for females (QTcB=QT\u002F R1\u002F2);\n    * Had myocardial infarction, bypass surgery or stent surgery within 6 months before the study;\n    * Other heart diseases judged by the researchers as unsuitable for inclusion in the group;\n13. Have received live vaccines within 6 weeks before screening.\n14. Patients participating in any other interventional clinical study or receiving treatment of an active investigational drug within 3 months or 5 half-lives for launched drugs prior to Inaticabtagene Autoleucel Injection infusion.\n15. Patients with a history of epilepsy, cerebral ischemia\u002Fhemorrhage, cerebellar diseases, or other active central nervous system disorders;\n16. Patients with hypersensitivity reactions to the components of Inaticabtagene Autoleucel Injection;\n17. Patients previously received CAR-T cell therapy.\n18. Other circumstances where the researcher deems it inappropriate to participate in this clinical trial.",{"count":75,"type":21},12,[77],"PHASE1","This is a multicenter, open-label, single-arm Phase I clinical trial to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection treatment in autoimmune hemolytic anemia that has failed at least three lines of treatment.",[80],"AIHA - Cold Autoimmune Hemolytic Anemia",[82,83],"AIHA","CarT","2025-09-17",{"date":86,"type":36},"2025-09-22",{"date":88,"type":21},"2025-12-27",{"date":90,"type":21},"2028-03-30",{"name":42,"class":43},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":99,"maxAge":17,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100490544","phase-1-a-study-of-cnct19-treatment-in-children-and-adolescent-rr-all-patientspediatric-100490544","NCT05667506","A Study of CNCT19 Treatment in Children and Adolescent r\u002Fr ALL Patients(Pediatric)","A Phase Ib\u002FII, Single Arm, Multi-center Study Evaluating the Safety and Efficacy of CNCT19 in Children and Adolescent(Pediatric) Patients With Relapsed\u002FRefractory B-precursor Acute Lymphoblastic Leukemia (r\u002Fr B-ALL)","Key Inclusion Criteria:\n\n1. Signed written informed consent prior to any study procedures (patient and\u002For parent or legal guardian)\n2. Age 3 to 18. Weight ≥10kg\n3. Relapsed or refractory acute lymphoblastic leukemia (ALL).\n4. Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening.\n5. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.\n6. Karnofsky (age ≥ 16 years) performance status ≥ 70 or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening\n7. Organ function requirements: All patients must have adequate renal and liver functions\n\nKey Exclusion Criteria:\n\n1. Active Central Nervous System (CNS) involvement by malignancy.\n2. Isolated extra-medullary disease relapse.\n3. Patients with Burkitt's lymphoma\u002Fleukemia, mixed phenotypic acute leukemia and Chronic Myelogenous Leukemia in Blast Crisis\n4. History of concomitant genetic syndrome\n5. Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening.\n6. Active systemic autoimmune disease\n7. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive).\n8. Patients with active infections at screening.\n9. Patients who received specified chemotherapy before CNCT19 infusion\n10. Radiotherapy before CNCT19 infusion:\n\n    Non-CNS site of radiation completed \\\u003C 4 weeks prior to CNCT19 Infusion; CNS directed radiation completed \\\u003C 8 weeks prior to CNCT19 infusion.\n11. Donor lymphocyte infusion (DLI) must be stopped \\> 6 week prior to CNCT19 infusion.\n12. Has had treatment with any prior CAR-T therapy.\n13. Life expectancy \\\u003C 3 months.","3 Years",{"count":101,"type":21},47,[77,103],"PHASE2","This is a multi-center, phase Ib\u002FII trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r\u002Fr B-cell ALL).",[106],"B-cell Acute Lymphoblastic Leukemia",[30,108,109],"Cluster of differentiation antigen 19(CD19)","CD19-directed CAR-T cells","2025-08-11",{"date":112,"type":36},"2025-08-12",{"date":114,"type":36},"2023-02-07",{"date":116,"type":21},"2027-05-30",{"name":42,"class":43},9,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":136,"leadSponsor":138,"locationsCount":44},"100579602","phase-1-inaticabtagene-autoleucel-injection-in-the-treatment-of-refractory-systemic-lupus-erythematosus-related-immune-thrombocytopenia-100579602","NCT06826430","Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia","A Multi-center, Open-label, Single-arm Phase I Clinical Study to Evaluate the Safety and Tolerability of Inaticabtagene Autoleucel Injection in Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia","Inclusion Criteria:\n\n1. Age range: 18-70 years (including 18 and 70 years), regardless of gender.\n2. Clinically diagnosed with Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia according to the revised criteria of ACR in 1997 or EULAR\u002FACR in 2019. At least two consecutive blood routine tests showing platelet counts \\\u003C50×10\\^9\u002FL; Peripheral blood smear microscopy showed no significant abnormalities in the morphology of blood cells; The morphological characteristics of bone marrow cells are consistent with immune thrombocytopenia. Treated at least 1 course of MP shock therapy or high-dose steroids, combined with one or more immunosuppressive agents (including biologics) for at least 3 months but not achieving partial remission, or the efficacy cannot be maintained during the steroid reduction process.\n3. During the study period, the use of corticosteroids at a dose not exceeding 10mg prednisone or its equivalent, all immunosuppressants (excluding hydroxychloroquine) should be discontinued.\n4. Women of childbearing potential must have a negative blood pregnancy test 7 days prior to trial conditioning therapy; any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least 2 year following infusion of CAR-T cells. Childbearing potential is biologically capable of bearing a living baby and sexually active. Female patients who were not of childbearing potential (ie, met at least 1 of the following criteria):\n\n   * Hysterectomy or oophorectomy, or\n   * Medically confirmed ovarian failure, or medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months in the absence of pathological or physiological causes).\n5. Adequate organ function according to the following criteria:\n\n   * Aspartate aminotransferase (AST) ≤ 3 times of upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) ≤ 3 times ULN;\n   * Total serum bilirubin ≤ 2 times ULN unless the patient has documented Gilbert's syndrome; patients with Gilbert's syndrome who have bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included;\n   * Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft and Gault formula), Patients with lupus nephritis may relax the conditions appropriately according to the judgment of the investigator;\n   * Must have minimal pulmonary reserve and oxygen saturation \\> 91% in a nonoxygenated state;\n   * Lymphocyte count \\> 0.4 × 109\u002FL.\n\nExclusion Criteria:\n\n1. Severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents, or CNS vasculitis requiring therapeutic intervention within 60 days after baseline.\n2. Dialysis patients or creatinine clearance rate less than 30mL\u002Fmin.\n3. Pregnancy or breastfeeding.\n4. Merge active infections (such as sepsis, bacteremia, mycosis, uncontrolled lung infections, and active tuberculosis).\n5. Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and\u002For hepatitis B core antibody (HBcAb) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit; Hepatitis C (HCV) antibody positive; positive for human immunodeficiency virus (HIV) antibodies; positive for syphilis antibody (TP Ab);\n6. Major surgery that was assessed as unsuitable by the investigators within 4 weeks before screening.\n7. Patients with concurrent active malignancy within the past five years, those with a history of malignancy but cuired are eligible.\n8. The patient's heart meets any of the following conditions:\n\n   Left ventricular ejection fraction (LVEF) ≤ 45%; New York Heart Association (NYHA) Grade III or IV congestive heart failure or active heart disease; Severe arrhythmias that require treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia); QTcB interval ≥ 450ms for males and ≥ 470ms for females (QTcB=QT\u002FRR1\u002F2); Have had myocardial infarction, bypass or stent surgery within the 6 months prior to the study; Other heart diseases that have been determined by researchers to be unsuitable for inclusion;\n9. Patients with clinically significant pleural effusion during screening.\n10. Patients vaccinated with a live vaccine within 6 weeks prior to screening.\n11. Patients with deep vein thrombosis within 6 months prior to screening, or a history of pulmonary embolism.\n12. Patients with a life expectancy of less than 6 months.\n13. Patients participating in any other interventional clinical study or receiving treatment of an active investigational drug within 3 months or 5 half-lives for launched drugs prior to Inaticabtagene Autoleucel Injection infusion.\n14. Patients with a history of epilepsy, cerebral ischemia\u002Fhemorrhage, cerebellar diseases, or other active central nervous system disorders;\n15. Patients with hypersensitivity reactions to the components of Inaticabtagene Autoleucel Injection.\n16. Patients previously received CAR-T cell therapy.","70 Years",{"count":75,"type":21},[77],"This is a single-arm, open-label，phase I clinical study to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection in treatment of refractory systemic lupus erythematosus-related immune thrombocytopenia.",[131],"Autoimmune Thrombocytopenia","2025-08-06",{"date":134,"type":36},"2025-08-07",{"date":38,"type":36},{"date":137,"type":21},"2027-12-31",{"name":42,"class":43},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":44},"100551535","long-term-observational-study-of-patients-treated-with-inaticabtagene-autoleucel-injection-100551535","NCT06461351","Long-term Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection","A Long Term Follow-up Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection","Inclusion Criteria:\n\n1. Agree to sign an informed consent form for long-term follow-up studies.\n2. Registered clinical trial patients with different indications for this product who have received at least one infusion of Inaticabtagene Autoleucel Injection in the past, as well as post market commercialized patients.\n\nExclusion Criteria:\n\n\\- None.",{"count":147,"type":21},1000,"OBSERVATIONAL","This clinical trial adopts an observational research method to conduct annual follow-up and monitoring of patients receiving treatment with Inaticabtagene Autoleucel Injection after its commercialization, in order to evaluate the delayed adverse events of Inaticabtagene Autoleucel Injection.",[151],"B-cell Tumors",{"date":134,"type":36},{"date":154,"type":36},"2024-03-30",{"date":156,"type":21},"2040-03-30",{"name":42,"class":43},{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},"100415017","phase-2-clinical-trial-of-cnct19-cell-injection-in-the-treatment-of-relapsed-or-refractory-acute-lymphoblastic-leukemia-100415017","NCT04684147","Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia","Phase Ⅱ Clinical Trial of CNCT19 Cell Injection in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Informed consent is signed by the subject.\n2. Age 18 to 65.\n3. Relapsed or refractory acute lymphoblastic leukemia (ALL). (1) Relapse within 12 months of first remission; (2)a. Without remission after more than 6 weeks of induction chemotherapy or without remission after 2 cycles of induction chemotherapy regimen; c. 2nd or greater Bone Marrow (BM) relapse OR; d. First relapse after chemotherapy, without remission after at least 1 rescue treatment; e. Any BM relapse after autologous or allogeneic stem cell transplantation (SCT).\n4. Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months of study entry.\n5. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 generation of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a T315I mutation.\n6. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.\n7. Eastern cooperative oncology group (ECOG) performance status of 0 to 1.\n8. Adequate organ function defined as:\n\n   1. aspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN);\n   2. Serum alanine aminotransferase (ALT) ≤ 3 upper limit of normal (ULN);\n   3. Total bilirubin ≤ 2 ULN, except in individuals with Gilbert's syndrome; Note: Patients with Gilbert's syndrome that bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN will be eligible;\n   4. A serum creatinine≤ 1.5 ULN or Creatine removal rate ≥ 60mL\u002Fmin (Cockcroft and Gault）;\n   5. Must have a minimum level of pulmonary reserve as ≤ Grade 1 dyspnea and oxygen saturation \\> 91% on room air;\n   6. International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (APTT) ≤ 1.5 ULN.\n9. Vascular conditions for apheresis.\n10. Women of childbearing age have a negative blood \u002F urine pregnancy test within 3 days before apheresis and the CNCT19 infusion. Women of child-bearing potential and all male participants must use highly effective methods of contraception throughout the study and for a period of at least two years after the CNCT19 infusion.\n\nExclusion Criteria:\n\n1. Active Central Nervous System (CNS) involvement by malignancy.\n2. Isolated extra-medullary disease relapse.\n3. Patients who received chemotherapy within 2 weeks before CNCT19 infusion. The following situations are excluded:\n\n   1. Lymphodepleting Chemotherapy prescribed by the protocol;\n   2. Tyrosine kinase inhibitors (TKI) and hydroxyurea must be stopped \\> 72 hours prior to CNCT19 infusion;\n   3. The following drugs must be stopped \\> 1 week prior to CNCT19 infusion: 6-mercaptopurine, 6-thioguanine, methotrexate (\\\u003C25 mg \u002F m2), cytosine arabinoside (\\\u003C100 mg \u002F m2 \u002F d), vincristine, asparaginase;\n   4. CNS prophylaxis treatment must be stopped \\> 1 week prior to CNCT19 infusion;\n   5. Pegylated-asparaginase must be stopped \\> 4 weeks prior to CNCT19 infusion.\n4. Radiotherapy before CNCT19 infusion:\n\n   Non-CNS site of radiation completed \\\u003C 2 weeks prior to CNCT19 Infusion; CNS directed radiation completed \\\u003C 8 weeks prior to CNCT19 infusion.\n5. Therapeutic systemic doses of steroids were stopped \\\u003C 72 hours prior to CNCT19 infusion. However, the following physiological replacement doses of steroids are allowed: \\\u003C 10 mg\u002Fday hydrocortisone or equivalent.\n6. Has received anthracycline\u002Fanthraquinone drug treatment exceeding the maximum cumulative dose recommended by the guidelines, estimated by investigators before screening, as follows:\n\n   * Doxorubicin: 550mg\u002Fm2 (radiotherapy or combined medication, \\\u003C(radiotherapy or combined medication, \\\u003C350\\~400 mg\u002Fm2);\n   * Epirubicin: 900\\~1000 mg\u002Fm2 (Adriamycin used, \\\u003C800 mg\u002Fm2);\n   * Pirarubicin: 950 mg\u002Fm2;\n   * Daunorubicin: 550 mg\u002Fm2;\n   * Demethoxydaunorubicin: 290 mg\u002Fm2;\n   * Aclarithromycin: 2000 mg\u002Fm2 (Adriamycin used, \\\u003C800 mg\u002Fm2);\n   * Mitoxantrone: 160 mg\u002Fm2 (using doxorubicin, \\\u003C120 mg\u002Fm2);\n7. Has had treatment with any prior CAR-T therapy.\n8. Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening; Patients who have received systemic drug therapy for GVHD within 4 weeks before CNCT19 infusion.\n9. Patients with systemic vasculitis.\n10. Patients complying with any of hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection, hepatitis C antibody (HCV-Ab) positive, anti-treponemia pallidum antibody (TP-Ab) positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection.\n11. Prior malignancy. Patients with Prior malignancy that has been cured for ≥ 5 years or has a low risk of relapse, judged by investigators are excluded.\n12. a. Left Ventricular Ejection Fraction (LVEF) ≤45%; b. III\u002FIV congestive heart failure (NYHA); c. Severe arrhythmia, or clinically significant conduction abnormalities that can be seen on ECG, including QTc interval ≥480ms (QTcB=QT\u002FRR1\u002F2); d. Hypertension that has not been controlled after standard treatment (systolic ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg); e. Unstable angina; f. Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery \\\u003C 6 months prior to CNCT19 infusion; f. Clinically significant valvular disease; g. Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy.\n13. Clinically significant pleural effusion.\n14. Patients with a history of epilepsy, cerebrovascular ischemia \u002F hemorrhage, cerebellar disease or other active central nervous system diseases.\n15. History of deep vein thrombosis or pulmonary embolism within 6 months of screening.\n16. Known history of hypersensitivity to ingredients used in the drug.\n17. Has had treat with live vaccine within 6 weeks prior to screening.\n18. Patients with active infections in screening.\n19. Life expectancy \\\u003C 3 months.\n20. Patient in other interventional clinical studies, who received live investigational product, including: Unlisted new drugs within 3 months before CNCT19 injection, marketed drug within 5 half-lives before CNCT19 injection, or who intend to participate in another clinical trial or receive anti-tumor therapy outside the protocol during the entire study.\n21. Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.","65 Years",{"count":167,"type":21},100,[103],"The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.",[171],"Relapsed or Refractory Acute Lymphoblastic Leukemia",{"date":173,"type":36},"2025-08-08",{"date":175,"type":36},"2020-12-24",{"date":177,"type":21},"2026-12-31",{"name":42,"class":43},11,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":126,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":44},"100540434","early-phase-1-exploratory-clinical-study-of-cnct19-anti-cd19-cell-therapy-in-the-treatment-of-refractory-autoimmune-diseases-100540434","NCT06316791","Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. The enrolled subjects or their legal representatives signed informed consent form;\n2. age range: 18-70 years (including 18 and 70 years), male or female;\n3. Subjects with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia) : Diagnosed with systemic lupus erythematosus according to American College of Rheumatology (ACR) criteria, accompanied by lupus nephritis (SLE-LN) or immune thrombocytopenia (SLE-ITP) and receiving standard treatment;\n\n   1. Subjects with Refractory Systemic Lupus Erythematosus (Lupus Nephritis): Active and biopsy-confirmed proliferative lupus nephritis grade III or IV or simple grade V alone according to 2003 ISN\u002FRPS criteria. Active renal disease was defined as a urine protein: creatinine ratio \\> 1.0 or proteinuria \\> 3.5 grams\u002Fday.\n   2. Subjects with refractory systemic lupus erythematosus (thrombocytopenia): At least two consecutive blood routine examinations showed that platelet was lower than 50x109\u002FL; Blood cell morphology of peripheral blood smear was normal. The spleen is generally not enlarged; The morphological characteristics of bone marrow cells were megakaryocytic increase or normal, accompanied by maturation disorder. Platelet count \\> 10 x10\\^9 \u002F L.\n4. Subjects with refractory ANCA-associated vasculitis: diagnosis of ANCA glomerulonephritis (GN) or vasculitis based on the 2013 American Chapel Hill Consensus Conference definition of AAV ;\n\n   * Relapsed or refractory AAV requiring treatment with cyclophosphamide or rituximab\n   * Newly diagnosed or recurrent AAV--, defined as accumulation of at least one major organ (e.g., kidney, lung, heart) requiring induction therapy with cyclophosphamide or rituximab;\n   * Anti-PR3 or anti-MPO positive (current or history);\n5. Subjects with Refractory Dermatomyositis: Refractory MDA5-positive dermatomyositis is defined as active disease and meets the following conditions: adequate corticosteroid therapy (greater than two to four weeks of conventional corticosteroid therapy or intolerance to such therapy) and\u002For\n\n   * Use of ≥ 1 conventional immunosuppressive agent (eg, methotrexate, azathioprine, tacrolimus, cyclosporine, mycophenolate mofetil, IVIG, anti-TNF, or rituximab) at a reasonable dose and duration (greater than two to four weeks or intolerance to therapy);\n   * Treatment with IVIG or cyclophosphamide for two to four weeks.\n6. Women of childbearing potential must have a negative blood pregnancy test 7 days prior to trial conditioning therapy; any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least 1 year following reinfusion of CNCT19 CAR-T cells. Childbearing potential, in the judgment of the investigator, is biologically capable of bearing a living baby and sexually active. Female patients who were not of childbearing potential (ie, met at least 1 of the following criteria):\n\n   * Hysterectomy or oophorectomy, or\n   * Medically confirmed ovarian failure, or medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months in the absence of pathological or physiological causes).\n7. Adequate organ function according to the following criteria:\n\n   * Aspartate aminotransferase (AST) ≤ 3 times of upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) ≤ 3 times ULN;\n   * Total serum bilirubin ≤ 2 times ULN unless the patient has documented Gilbert's syndrome; patients with Gilbert's syndrome who have bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included;\n   * Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft and Gault formula), Patients with lupus nephritis may relax the conditions appropriately according to the judgment of the investigator;\n   * Must have minimal pulmonary reserve and oxygen saturation \\> 91% in a nonoxygenated state;\n   * Lymphocyte count \\> 0.4 × 109\u002FL.\n\nExclusion Criteria:\n\n1. Patients with severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accident or CNS vasculitis requiring therapeutic intervention within 60 days after baseline;\n2. Dialysis patients;\n3. Pregnancy or lactation;\n4. Concomitant uncontrollable infection (e.g., sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, etc.);\n5. Hepatitis B surface antigen (HBsAg) positive and hepatitis C (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis (TP) positive;\n6. Major surgery that was assessed as unsuitable by the investigator within 4 weeks before screening;\n7. Patient's heart meets any of the following:\n\n   * Left ventricular ejection fraction (LVEF) ≤ 45%;\n   * New York Heart Association (NYHA) Class III or IV congestive heart failure or active cardiac disease;\n   * Serious arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia);\n   * QTc interval ≥ 450 ms for males and ≥ 470 ms for females (QTcB = QT\u002FRR1\u002F2);\n   * Myocardial infarction, bypass surgery or stent surgery within 6 months prior to the study;\n   * Other cardiac diseases that are not suitable for the study as judged by the investigator;\n8. Received live vaccine within 6 weeks prior to screening.\n9. Participation in other interventional clinical studies within 3 months prior to cell infusion, treatment with an active experimental drug, or intentional participation in another clinical trial or treatment outside of that specified by the protocol throughout the study period.\n10. Patients with a history of epilepsy or other active central nervous system diseases;\n11. Known hypersensitivity to the ingredients of the preparation used in the test;\n12. Prior treatment with CAR-T cells.\n13. Other conditions that the investigator considers inappropriate for participation in this clinical trial.",{"count":187,"type":21},24,[24],"Exploratory clinical study of CNCT19 anti CD19 cell therapy in the treatment of refractory autoimmune diseases,To evaluate the safety and tolerability of CNCT19 in patients with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis on the basis of standard of care.",[191],"Lupus Erythematosus, Systemic",[30,109],"2025-02-06",{"date":195,"type":36},"2025-02-10",{"date":197,"type":36},"2021-12-14",{"date":199,"type":21},"2025-12-13",{"name":42,"class":43},{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},"100407519","phase-2-phase-ii-clinical-trial-of-cnct19-cell-injection-in-the-treatment-of-relapsed-or-refractory-non-hodgkins-lymphoma-100407519","NCT04586478","Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n1. Patients who are willing to sign the informed consent form;\n2. Aged 18-75 years, male or female;\n3. At screening, subjects complying with the following diagnostic and treatment requirements:\n\n   1. Complying with CD19-positive NHL according to the WHO classification 2017, which are provided specifically as follows:\n\n      * Diffuse large B cell lymphoma (DLBCL), not otherwise specified (NOS);\n      * Primary mediastinal large B cell lymphoma (PMBCL);\n      * Transformed follicular lymphoma\n      * High grade B cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, and high grade B cell lymphoma - not otherwise specified.\n   2. Previously received≥2nd-line adequate therapy or autologous hematopoietic stem cell transplantation (ASCT), including:\n\n      * Received at least Rituximab or other CD20 targeted drugs containing (except CD20 negative tumors) chemotherapy and\n      * Received at least one chemotherapy regimen containing anthracycline;\n      * Definition of line: Stable disease (SD) after receiving a first-line adequate therapy or progressive disease (PD), and SD after a second-line therapy for at least 2 cycles or PD .\n   3. In relapsed or refractory status at screening:\n\n      * Definition of relapse: Remission (including partial remission (PR) or complete remission (CR)) after treatment with at least the standard therapy regimen (it must contain Ribuximab), and then PD;\n      * Definition of refractoriness:\n\n   Non-responsiveness to the last therapy: The best response by the last therapy is SD or PD; Relapse or progression after ASCT, including: Relapse (it must be proved by biopsy) or PD within 12 months after ASCT; if a rescue therapy is received, the patient is non-responsive (SD or PD) to the last therapy;\n\n   For transformed follicular lymphoma (TFL), patients must be treated adequately against FL, and after transformation, must have received at least once the therapy against TFL, and become relapsed or refractory after the last therapy.\n4. Measurable imaging lesion at screening: Intranodal lesion must have a long diameter of more than 1.5 cm, and extranodal lesion must have a long diameter of more than 1.0 cm (per revised IWG Response Criteria 2014 in Lymphomas);\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n6. Adequate bone marrow reserve, defined as:\n\n   * Absolute neutrophil count (ANC) \\> 1.0×109\u002FL;\n   * Absolute lymphocyte count (ALC) ≥ 0.3×109\u002FL;\n   * Platelet (PLT) ≥50×109\u002FL;\n7. Proper organ function, complying with the following criteria (except hepatic dysfunction due to tumor cell infiltration): Aspartate aminotransferase (AST) ≤ 3 Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) ≤ 3 ULN; Total serum bilirubin ≤ 2 ULN, unless there exists concurrent Gilbert syndrome; patients with Gilbert syndrome, with total serum bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN, may be included; Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula); Minimum pulmonary reserve, defined as Grade ≤ 1 dyspnea, and blood oxygen saturation \\> 91% at non-oxygen inhalation status; International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 ULN.\n8. Vascular conditions for apheresis;\n9. Women with child-bearing potential are negative in blood\u002Furine pregnancy tests within 3 d prior to apheresis, and prior to infusion of CNCT19 cell injection infusion; any male or female patient with child-bearing potential must agree to adopt effective contraceptive measures throughout the study, and at least a year after administration of the investigational therapy. As judged by the investigator, a patient with child-bearing potential means that: He\u002Fshe has normal sexual life and is biologically fertile to have children. Non-fertile female patients (i.e., complying one of the following criteria):Previously received hysterectomy, bilateral ovariectomy, or bilateral tubal ligation, or Medically confirmed ovarian failure, or Medically confirmed postmenopause (amenorrhea of at least 12 consecutive months).\n\nExclusion Criteria:\n\n1. Patients with active central nervous system (CNS) lymphoma (a patient with CNS disease symptoms must receive lumbar puncture and MRI\u002FCT to exclude CNS lymphoma).\n2. Patients with existing central nervous system disease or with a history of central nervous system disease, e.g., epileptic seizure, cerebral ischemia\u002Fhemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellum disease, organic brain syndrome, mental disease, or any autoimmune disease involved with central nervous system.\n3. Patients receiving any of the following drugs or therapies within the specified period prior to apheresis:\n\n   * Alemtuzumab within 6 months prior to apheresis;\n   * Cladribine within 3 months prior to apheresis;\n   * Anti-CD20 monoclonal antibody within 7 d prior to apheresis;\n   * Venetoclax (BCL-2 inhibitor) within 4 d prior to apheresis;\n   * Idelalisib (PI3Kδ kinase inhibitor) within 2 d prior to apheresis;\n   * Lenalidomide within 1 d prior to apheresis;\n   * Lymphocytotoxic chemotherapy within 2 weeks prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;\n   * Non-lymphocytotoxic chemotherapy within 7 d prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;\n   * Radiotherapy within 6 weeks prior to apheresis, including big bone marrow area (e.g., sternum or pelvis) - progressive disease at radiotherapy site, or PET positive lesion at other non-radiotherapy site is eligible; if there is existing PET positive lesion in other non-radiotherapy sites, then it is allowable to conduct radiotherapy at a single lesion within 2 weeks prior to apheresis.\n4. Patients receiving chemotherapy within 2 weeks prior to CNCT19 Cell injection infusion, excluding the following conditions:\n\n   * Pretreatment chemotherapy as specified by the protocol;\n   * CNS lymphoma prophylaxis by intrathecal injection (it must be stopped within 1 week prior to infusion of CNCT19 Cell Injection).\n5. Discontinuation of a systematic therapeutic hormone within 72 h prior to infusion of CNCT19 Cell Injection; however, use of the hormone in the physiological surrogate amount is eligible (e.g., Prednisone in a dose of \\\u003C10 mg\u002Fd or equivalent).\n6. Patients previously received CAR-T cell therapy.\n7. Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n8. Patients with known active or uncontrolled synstemic autoimmune disease and under treatment.\n9. Patients complying with any of hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection, hepatitis C antibody (HCV-Ab) positive, anti-treponemia pallidum antibody (TP-Ab) positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection.\n10. Patients who received a major surgery within 4 weeks prior to screening, and are not eligible for enrollment as judged by the investigator.\n11. Patients with concurrent active malignancy; those with a history of malignancy, cured for≥2 years, are eligible.\n12. Patients complying any of the following conditions: Left ventricular ejection fraction (LVEF) ≤45% (ECHO); New York Heart Association (NYHA) Grade III or IV congestive heart failure; Uncontrolled hypertension (systolic blood pressures≥140mmHg and\u002For diastolic blood pressures ≥90 mmHg), pulmonary hypertension, or unstable angina pectoris; Myocardial infarction or bridging or stent procedure within 12 months prior to administration of the drug; Clinically significant valvular heart disease; Other heart diseases unsuitable for enrollment, as judged by the investigator.\n13. Patients with lymphoma involved with atrium or ventricle.\n14. Patients with clinical emergency (e.g., intestinal infarction or vascular compression) requiring treatment, due to existing lymphoma body obstruction or compression at screening.\n15. Patients with active hemorrhage at screening.\n16. Patients with deep vein thrombosis within 6 months prior to screening, or a history of pulmonary embolism.\n17. Patients who are known with a history of hypersensitivity reaction to any ingredient used for the drug product in the trial.\n18. Patients vaccinated with a live vaccine within 6 weeks prior to screening.\n19. Patients with active infection at screening.\n20. Patients with a life expectancy of less than 3 months.\n21. Patients participating in any other interventional clinical study or receiving treatment of an active investigational drug within 3 half-lives prior to CNCT19 Cell Injection infusion.",{"count":208,"type":21},60,[103],"The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of relapsed or refractory NHL.",[212],"Non-Hodgkin's Lymphoma",{"date":214,"type":36},"2025-02-07",{"date":216,"type":36},"2020-10-26",{"date":218,"type":21},"2025-09-30",{"name":42,"class":43},17,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":5},"100550668","inaticabtagene-autoleucel-injection-treatment-for-adult-relapsed-or-refractory-acute-lymphocytic-leukemia-100550668","NCT06450067","Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia","To Observe and Evaluate the Efficacy and Safety of Inaticabtagene Autoleucel Injection in the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia in Adults in the Real World","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia;\n3. Patients deemed eligible for receiving commercial Inaticabtagene Autoleucel injection treatment as determined by the investigator;\n4. Patients voluntarily participate in this study and sign an informed consent form. For patients lacking full legal capacity, informed consent must be obtained from their legal guardian\n\nExclusion Criteria:\n\nNone",{"count":229,"type":21},200,"This clinical trial is a non-interventional, observational, multicenter, post-marketing real-world study to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in Chinese adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.",[106],"2024-09-18",{"date":234,"type":36},"2024-09-19",{"date":236,"type":36},"2024-06-05",{"date":238,"type":21},"2029-06-05",{"name":42,"class":43},""]