[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640378":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":36,"responsibleParty":57,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":30,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":30,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":38,"whyStopped":30,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T cells chimeric antigen receptor T cells","EXPERIMENTAL","CT0890B cells infusion",[13],"Drug: CAR-T cells chimeric antigen receptor T cells",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Conditioning regimen:\n\nDays -9 to -3:\n\nVenetoclax administered with a target dose of 200 mg\u002Fday.\n\nDays -5 to -4:\n\nCytarabine administered at 500 mg\u002Fm²\u002Fday.\n\nDays -5 to -3:\n\nCyclophosphamide at 300 mg\u002Fm²\u002Fday plus Fludarabine at 30 mg\u002Fm²\u002Fday.\n\nDay 0:\n\nInfusion of CT0890B CAR-T cells at one of four dose levels using an i3+3 Dose-Escalation Design:\n\n1.5 × 10⁸ total cells, 3.0 × 10⁸ total cells, 4.5 × 10⁸ total cells, 6.0 × 10⁸ total cells",[9],[20],"Off-the-shelf allogeneic CAR-T cells",[22],{"name":23,"affiliation":5,"role":24},"XiangYu Zhao, M.D, Ph.D","PRINCIPAL_INVESTIGATOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Xiangyu Zhao, M.D,Ph.D","CONTACT","010-88325531",null,"Zhao_xy@bjmu.edu.cn",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Meng Lv, M.D., Ph.D","010-88316617","drlvmeng@bjmu.edu.cn",[37],{"facility":5,"status":38,"city":39,"state":30,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Beijing","100044","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50,52,54],{"name":51,"role":28,"phone":34,"phoneExt":30,"email":35},"Meng Lv, M.D,Ph.D",{"name":53,"role":24,"phone":30,"phoneExt":30,"email":30},"Xiangyu Zhao, M.D, Ph.D",{"name":55,"role":56,"phone":30,"phoneExt":30,"email":30},"Meng Lv, M.D, Ph.D","SUB_INVESTIGATOR",{"type":24,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Xiangyu Zhao","Principal Investigator",[61],{"name":62,"class":63},"CARsgen Therapeutics Co., Ltd.","INDUSTRY","100640378","phase-1-allogeneic-car-tct0890b-in-nkg2dl-rr-aml-100640378",false,"NCT07617285","Allogeneic CAR-T(CT0890B) in NKG2DL+ R\u002FR AML","A Phase I Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Cells (CT0890B) in Patients With NKG2DL-Positive Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Age 18-70 years (inclusive), male or female.\n2. Relapsed or refractory acute myeloid leukemia (R\u002FR AML) diagnosed according to the 2022 World Health Organization classification or ELN criteria, with confirmed NKG2D ligand-positive disease.\n3. Bone marrow blasts ≥5% by morphology.\n4. Estimated life expectancy \\>12 weeks.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n6. Adequate organ function without ongoing supportive care, defined as:\n\n   1. Cardiac: left ventricular ejection fraction (LVEF) ≥50%;\n   2. Hepatic: ALT and AST ≤2.5 × upper limit of normal (ULN), and total bilirubin ≤2 × ULN;\n   3. Renal: creatinine clearance ≥30 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n   4. Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.\n\n   c) Renal: creatinine clearance ≥30 mL\u002Fmin (calculated using the Cockcroft-Gault formula); d) Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.\n\nExclusion Criteria:\n\n1. Participants were diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), central nervous system leukemia;\n2. Participants with a history of epilepsy or other central nervous system disease;\n3. Participants who have previously received autologous or allogeneic CAR-T therapy;\n4. Participants who have received autologous stem cell transplantation or allogeneic stem cell transplantation within 12 weeks\n5. Participants who have received prior immunotherapy targeting NKG2DL;\n6. Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD;\n7. Participant has any of the following at screening:\n\n1)Active, uncontrolled systemic infection or requiring intravenous anti-infective agents 2)Any of the following cardiac conditions, including:\n\n1. New York Heart Association Class III-IV heart failure;\n2. History of myocardial infarction, coronary artery bypass grafting, or unstable angina within 6 months prior to Qinglin;\n3. History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia;\n4. History of severe nonischemic ardiomyopathy;\n5. Other cardiac disease that the investigatorbelieve could jeopardize the participant 's well-being or compromise participation in this clinical trial; 3) Active bleeding of clinical significance as judged by the investigator; 4)Requiring supplemental oxygen to maintain oxygen saturation\\> 92%; 5)Patients with severe chronic obstructive pulmonary disease (COPD) or other lung diseases that cannot tolerate CAR-T treatment as judged by the investigator;","ALL","18 Years","70 Years",{"count":75,"type":76},27,"ESTIMATED","INTERVENTIONAL",[79],"PHASE1","A Clinical Study to Investigate the Safety and Efficacy of CT0890B in Patients with Relapsed\u002FRefractory Acute Myeloid Leukemia.",[82,83],"AML","Refractory\u002FRelapse Acute Myeloid Leukemia",[85,86,82],"CT0890B","Universal CAR-T","2026-05-23",{"date":89,"type":90},"2026-06-01","ACTUAL",{"date":92,"type":76},"2026-05-07",{"date":94,"type":76},"2029-12-31",{"name":5,"class":6},1]