NCT07617285招募中1 期
A Phase I Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Cells (CT0890B) in Patients With NKG2DL-Positive Relapsed/Refractory Acute Myeloid Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
研究概览
简要总结
A Clinical Study to Investigate the Safety and Efficacy of CT0890B in Patients with Relapsed/Refractory Acute Myeloid Leukemia.
详细描述
This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety, efficacy, and cellular pharmacokinetics of CT0890B in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 12~27 participants in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years (inclusive), male or female.
- •Relapsed or refractory acute myeloid leukemia (R/R AML) diagnosed according to the 2022 World Health Organization classification or ELN criteria, with confirmed NKG2D ligand-positive disease.
- •Bone marrow blasts ≥5% by morphology.
- •Estimated life expectancy >12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Adequate organ function without ongoing supportive care, defined as:
- •Cardiac: left ventricular ejection fraction (LVEF) ≥50%;
- •Hepatic: ALT and AST ≤2.5 × upper limit of normal (ULN), and total bilirubin ≤2 × ULN;
- •Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula);
- •Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.
- •c) Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula); d) Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.
排除标准
- •Participants were diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), central nervous system leukemia;
- •Participants with a history of epilepsy or other central nervous system disease;
- •Participants who have previously received autologous or allogeneic CAR-T therapy;
- •Participants who have received autologous stem cell transplantation or allogeneic stem cell transplantation within 12 weeks
- •Participants who have received prior immunotherapy targeting NKG2DL;
- •Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD;
- •Participant has any of the following at screening:
- •Active, uncontrolled systemic infection or requiring intravenous anti-infective agents 2)Any of the following cardiac conditions, including:
- •New York Heart Association Class III-IV heart failure;
- •History of myocardial infarction, coronary artery bypass grafting, or unstable angina within 6 months prior to Qinglin;
- •History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia;
- •History of severe nonischemic ardiomyopathy;
- •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;
研究者
Xiangyu Zhao
Principal Investigator
Peking University People's Hospital
研究点 (1)
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