[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"iCell Gene Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":167},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,83,114,141],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100643991","phase-1-anti-cd33-cll1-car-t-cells-icg415-for-the-treatment-of-relapsedrefractory-acute-myeloid-leukemia-100643991",false,"NCT07668557","Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia","A Clinical Study to Evaluate the Safety and Efficacy of ICG415 CAR-T Cells in Adult Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","ICG415-AML-01","Inclusion Criteria:\n\n1. Written informed consent approved by IRB\u002FIEC obtained from subject or legally authorized representative prior to any screening procedures.\n2. Age ≥ 18 years and ≤ 70 years at the time of informed consent signing.\n3. Diagnosis of acute myeloid leukemia (AML) per 2022 WHO Classification, meeting criteria for relapsed\u002Frefractory (R\u002FR) AML as defined in the Chinese Guidelines for the Diagnosis and Management of Relapsed\u002FRefractory Acute Myeloid Leukemia (2023 Edition): Relapsed AML: Reappearance of leukemic blasts in peripheral blood, bone marrow blasts ≥5%, or extramedullary leukemic infiltration after complete remission (CR). Refractory AML: failure to achieve CR after two cycles of standard induction chemotherapy; early relapse within 12 months post-CR; late relapse with salvage chemotherapy resistance; ≥2 disease relapses or persistent extramedullary disease.\n4. Bone marrow leukemic blasts positive for both CLL-1 and CD33 by flow cytometry.\n5. If circulating blasts are detectable at screening, tumor cell surface immunophenotype must be CD4 and CD8 double-negative by flow cytometry.\n6. ECOG performance status 0-2.\n7. Expected overall survival \\> 3 months.\n8. Females of childbearing potential: negative serum pregnancy test and effective contraception for 1 year post-infusion. Males of reproductive potential: effective barrier contraception for 1 year post-infusion and no sperm donation within 1 year after infusion.\n\nExclusion Criteria:\n\n1. Prior receipt of CAR-T cell therapy or other genetically modified cell therapy prior to informed consent.\n2. Severe major organ dysfunction: Renal: eGFR \\\u003C 50 mL\u002Fmin (Cockcroft-Gault); Hepatic: ALT\u002FAST \\> 3 × ULN (\\>5×ULN if disease-related), total bilirubin \\> 2 × ULN (\\>3×ULN for Gilbert syndrome); Cardiac: LVEF \\\u003C 50%, room air SpO₂ \\\u003C94%, uncontrolled severe cardiac disease.\n3. Active uncontrolled infection: positive HBsAg\u002FHBV-DNA, active HCV-RNA positivity, HIV positive, positive syphilis antibody, active uncontrolled EBV or CMV viremia.\n4. Unstable severe systemic disease requiring continuous medication.\n5. Grade \\>2 bleeding within 30 days before screening or chronic long-term anticoagulant treatment.\n6. Uncontrolled life-threatening bacterial, fungal or viral infection.\n7. Non-leukemic central nervous system organic disease or active CNS-2\u002FCNS-3 leukemia; previously treated and resolved CNS leukemia is permitted.\n8. Concurrent other malignant tumor except cured in-situ carcinoma or malignancies with ≥5 years continuous complete remission.\n9. Live-attenuated vaccines within 30 days before screening or planned within 3 months after CAR-T infusion.\n10. Received any other investigational medicinal product within 3 months prior to ICF signature.\n11. Allogeneic hematopoietic stem cell transplantation within 6 months before screening.\n12. Pregnant or breastfeeding women.\n13. Suicidal tendency, ongoing alcohol or illicit drug dependence.\n14. Known hypersensitivity to investigational product, excipients or concomitant drugs.\n15. Any other condition judged inappropriate for trial entry by investigator.","ALL","18 Years","70 Years",{"count":21,"type":22},18,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This single-arm, open-label phase I trial evaluates the safety and tolerability of ICG415, autologous CAR-T cells targeting CD33 and CLL1, in patients with relapsed or refractory acute myeloid leukemia (AML). Subjects receive lymphodepleting chemotherapy followed by autologous CAR-T infusion. The primary goal is to assess safety and preliminary anti-leukemic efficacy in patients failing standard AML therapies.",[28],"Acute Myeloid Leukemia (AML)",[30,31,32,33,34,35,36,37,38,39],"Acute Myeloid Leukemia","AML","Leukemia","Acute Leukemia","Myeloid Leukemia","CAR-T","Cellular Therapy","CD33-CLL1 CAR-T","Relapsed or Refractory","R\u002FR AML","RECRUITING","2026-06-19",{"date":43,"type":44},"2026-06-25","ACTUAL",{"date":46,"type":44},"2026-06-10",{"date":48,"type":22},"2029-07-04",{"name":50,"class":51},"iCell Gene Therapeutics","INDUSTRY",2,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100634782","phase-1-bcma-cd19-ccar-t-for-the-treatment-of-refractory-inflammatory-bowel-disease-ibd-100634782","NCT07544160","BCMA-CD19 cCAR T for the Treatment of Refractory Inflammatory Bowel Disease (IBD)","A Single-arm, Open-label Phase I Clinical Study to Evaluate ICG318 CAR-T in Adults With Refractory Inflammatory Bowel Disease","Key Inclusion criteria:\n\n1. All subjects or legal guardians must sign an ethics committee-approved informed consent form in writing prior to initiation of any screening procedures.\n2. Male or female subject over 18 years old and under 70 years old at the time of evaluation; Weight ≥ 40 kg.\n3. Diagnosed with inflammatory bowel disease assessed by the investigator and the disease course has been ≥ 3 months before signing informed consent (clinical manifestations, endoscopy and histopathological reports consistent with the diagnosis of inflammatory bowel disease are required).\n4. The subject has documented inadequate response, loss of response, or intolerance to at least one advanced therapy for IBD.\n5. Patients with IBD during the screening period need to meet the requirements of moderate to severe IBD; UC: active ulcerative colitis, defined as per the adapted Mayo score criteria. CD: CD subjects with moderate to severe active CD, defined as interpreted by SES-CD.\n6. Life expectancy greater than 6 months;\n7. Female individuals with fertility (defined as all females who are physiologically capable of becoming pregnant) must provide informed consent, have a negative blood pregnancy test result, and agree to use highly effective contraception from the time of informed consent until 1 year after CAR-T cell infusion. Male individuals with fertility must agree to use effective barrier contraception from the time of informed consent until 1 year after CAR-T cell infusion, and should not donate semen or sperm during the entire study period.\n8. Indeterminate colitis is permitted.\n\nKey Exclusion criteria:\n\n1. Subjects who have previously received any BCMA and\u002For CD19 targeted cell therapy products or CAR-T therapy for any target before signing the informed consent form.\n2. Undiagnosed type colitis, fulminant colitis, Hirschsprung-associated enterocolitis (HAEC), microscopic colitis, ischemic colitis, radiation colitis, colitis-related diverticular disease, or other colitis or enteritis type that may confound the evaluation of efficacy.\n3. Subjects with malignant tumors or dysplasia on endoscopy.\n4. Subjects with severely impaired vital organ function.\n5. Impaired bone marrow function.\n6. Active hepatitis B, HCV positive, HIV antibody positive, Treponema pallidum antibody positive, Active tuberculosis.\n7. Presence of any IBD related complications determined by the investigator to interfere with the study of ICG318 CAR-T in refractory IBD.\n8. History of bleeding within 30 days determined by the investigator to exclude the patient.\n9. Infectious diseases: subjects with acute, life-threatening bacterial, viral or fungal infections that have not been controlled.\n10. Hospitalization for IBD-related complications within 30 days prior to screening.\n\n11） Clinically significant central nervous system disease determined by the investigator to impair the subjects ability to participate safely in this trial.\n\n12） Subjects with prior or concurrent malignancies. Exceptions may be determined at the discretion of the investigator.\n\n13） Vaccination within 30 days before screening and vaccination within 3 months after planned cell ICG318 CAR-T infusion.\n\n14） Subjects who are receiving or have received another investigational drug or drugs without adequate washout time as determined by the principal investigator.\n\n15） Those who are judged by the investigator to be unfit for leukapheresis, or whose IBD disease severity and trajectory are not compatible with infusion with ICG318 CAR-T cells, or any critical steps of the trial evaluation such as but not limited to contraindications to colonoscopy.\n\n16） Female subjects who are pregnant or lactating. 17） Autoimmune diseases judged by the investigator to require systemic treatment and affect the evaluation of efficacy.\n\n18） Suicidal tendencies, tobacco use, substance use, or alcohol abuse as determined by the investigator.\n\n19） Those who have a history of a severe drug allergy, or are allergic to the test drug ingredients, excipients or combined therapeutic drugs.\n\n20） Other conditions that the investigator believes should not participate in this clinical trial.",{"count":21,"type":22},[25,62],"PHASE2","This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of ICG318 CAR-T (BCMA-CD19-IL-15\u002FIL15sushi cCAR T cells) in patients with relapsed and\u002For refractory inflammatory bowel disease.",[65],"Inflammatory Bowel Diseases (IBD)",[67,68,69,70,71,72,35,36],"Ulcerative Colitis","Crohn's disease","Inflammatory Bowel Disease","IBD","UC","CD","NOT_YET_RECRUITING","2026-04-15",{"date":76,"type":44},"2026-04-22",{"date":78,"type":22},"2026-04-07",{"date":80,"type":22},"2028-04-07",{"name":50,"class":51},1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":90,"maxAge":19,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100618204","phase-1-bcma-cd19-ccar-t-for-the-treatment-of-refractory-lupus-100618204","NCT07328581","BCMA-CD19 cCAR T for the Treatment of Refractory Lupus","Phase I, IIa, Single-Arm, Study of BCMA-CD19-IL-15\u002FIL15sushi cCAR T for the Treatment of Refractory Systemic Lupus Erythematosus, With or Without Lupus Nephritis","Key Inclusion Criteria:\n\n1. Age 16-70 years at the time of signing the informed consent\n2. Have a diagnosis of SLE by EULAR\u002FACR 2019 criteria for ≥6 months.\n3. Have at least one of an antinuclear antibody, anti-double-stranded deoxyribonucleic acid (dsDNA), or elevated anti-Smith (Sm) antibody\n4. Inadequate response to 2 prior standard of care therapies, used for at least three months\n5. SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥7 at Screening\n6. For LN cohort participants. Kidney biopsy result within 6 months prior to Screening indicating Class III or IV (alone or in combination with Class V)6.\n\nKey Exclusion Criteria:\n\n1. Any acute, severe lupus related flare that needs immediate treatment\n2. History of antiphospholipid syndrome with thromboembolic event within 12 months\n3. History or current diagnosis of any disease, condition or treatment that may confound clinical assessments in the study.\n4. Has drug-induced SLE.\n5. History of prior CAR-T therapy.\n6. History of bone marrow\u002Fhematopoietic stem cell or solid organ transplant or planned receipt during the study period.\n7. Recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection\n8. Receipt of a live\u002Flive-attenuated vaccine other than BCG within 8 weeks\n9. History within the past year or current clinically significant central nervous system disease, including but not limited to cerebrovascular accident, seizures, severe brain injury, dementia, Parkinson's disease, cerebellar disease, or multiple sclerosis\n10. Impaired cardiac function or clinically significant cardiac disease\n11. End stage renal disease or severe liver disease\n12. Breastfeeding\u002Flactating or pregnant women or women who intend to become pregnant at any time during the study.","16 Years",{"count":92,"type":22},20,[25,62],"This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19-IL-15\u002FIL15sushi cCAR T cells in patients with relapsed and\u002For refractory SLE, with or without Lupus Nephritis.",[96,97],"Systemic Lupus Erythematosus (SLE)","Lupus Nephritis (LN)",[99,100,101,102,103,104,97,105],"Lupus","autoimmune disease","CAR-T Cell","Refractory disease","CD19","BCMA","Systemic Lupus Erythrematosus (SLE)","2026-01-07",{"date":108,"type":44},"2026-01-09",{"date":110,"type":22},"2026-01",{"date":112,"type":22},"2028-12",{"name":50,"class":51},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":129,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":52},"100374967","phase-1-bcma-cd19-ccar-in-multiple-myeloma-and-plasmacytoid-lymphoma-100374967","NCT04162353","BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma","BCMA-CD19 cCAR in Relapsed and \u002For Refractory Multiple Myeloma and Plasmacytoid Lymphoma","Inclusion Criteria:\n\n* Signed written informed consent; Patients volunteer to participate in the research\n* Diagnosis is mainly based on the World Health Organization (WHO) 2008\n* Patients have exhausted standard therapeutic options\n* Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks\n* Female must be not pregnant during the study\n\nExclusion Criteria:\n\n* Patients declining to consent for treatment\n* Prior solid organ transplantation\n* Potentially curative therapy including chemotherapy or hematopoietic cell transplant\n* Prior treatment with BCMAxCD3 or CD19xCD3 bispecific agents",{"count":122,"type":22},12,[25],"This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR in patients with relapsed and\u002For refractory multiple myeloma and plasmacytoid lymphoma.",[126,127,128],"Multiple Myeloma in Relapse","Refractory Multiple Myeloma","Plasmacytoid; Lymphoma",[104,103,130,131,132],"BCMA-CD19 cCAR T cells","multiple myeloma","plasmacytoid lymphoma","2025-09-10",{"date":135,"type":44},"2025-09-16",{"date":137,"type":44},"2019-07-01",{"date":139,"type":22},"2026-07",{"name":50,"class":51},{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":82},"100576645","phase-1-bcma-cd19-ccar-t-cell-treatment-of-refractory-immune-thrombocytopenia-associated-with-autoimmune-diseases-100576645","NCT06787989","BCMA-CD19 CCAR T Cell Treatment of Refractory Immune Thrombocytopenia Associated with Autoimmune Diseases","Treatment of Refractory Immune Thrombocytopenia","Inclusion Criteria:\n\n* 1\\. Age: 18\\~60 years old; 2. Diagnosed with immune thrombocytopenia associated with autoimmune diseases including systemic lupus erythematosus (according to the 1997 or 2009 ACR classification criteria), primary Sjogren's syndrome (according to the 2002 ACR\u002FEULAR international classification criteria), undifferentiated connective tissue disease (according to the 1999 international classification criteria). Or patient without clinical manifestations related to connective tissue disease, but with positive anti nuclear antibodies (≥ 1:100) and\u002For without positive anti SSA\u002FRo-52 antibodies;Serum creatinine \\\u003C221.0μmol\u002FL (2.5mg\u002Fdl); 3. platelet count\\\u003C30 × 10 ⁹\u002FL or platelet count ≥ 20 × 10 ⁹\u002FL, accompanied by bleeding symptoms (bleeding symptom score ≥ 2 points). No obvious active infection; 4. Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative.\n\nExclusion Criteria:\n\n\\- 1. Serious accompanying diseases that researchers consider clinically significant due to poor control, such as (but not limited to) neurological, cardiovascular, renal, liver, endocrine, or gastrointestinal diseases CNS disease: Active central nervous system (CNS) lupus (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident \\[CVA\\], encephalitis or CNS vasculitis), visual Disorders, cranial neuropathy requiring intervention 2. Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) detection value is greater than 1.5 times the upper limit of normal (ULN);; urinary protein quantification\\>1g\u002F24h.\n\n3\\. History of malignant tumors 4. Active hepatitis B or C.，and HIV positive 5. Individuals with a history of drug allergies or allergies. 6. Have any other clinically significant disease history or current disease that, in the judgment of the research physician, may pose a risk to the safety of the subjects, or interfere with the completion of the research procedure and the evaluation of safety and efficacy.","60 Years",{"count":92,"type":22},[25],"This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with refractory ITP associated with autoimmune disease.",[153],"Refractory Immune Cytopenia",[155,156,157,158],"immune thrombocytopenia","CAR T cells","BCMA-CD19 cCAR","autoimmune diseaases","2025-01-16",{"date":161,"type":44},"2025-01-22",{"date":163,"type":44},"2024-08-31",{"date":165,"type":22},"2027-04",{"name":50,"class":51},""]