NCT07233018尚未招募1 期
A Clinical Study to Investigate the Safety and Efficacy of CT0991 in Patients With Relapsed/Refractory Acute Myeloid Leukemia.
MEI HENG1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年11月18日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- MTD and/or dose range
研究概览
简要总结
A Clinical Study to Investigate the Safety and Efficacy of CT0991 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 CT0991 in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 3-24 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in the clinical trial; Fully understand and are informed of this study and sign the informed consent form; Willing to follow and able to complete all trial procedures.
- •Age 18-75 years (inclusive), male or female.
- •Estimated survival > 12 weeks.
- •Patients with relapsed or refractory AML as defined in the Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (Version 2023);
- •Flow cytometry or immunohistochemical examination of bone marrow or peripheral blood samples showed positive expression of CD38 in tumor cells and the expression rate was ≥80%.
- •ECOG score 0-
- •Participants should meet the following test results (no ongoing supportive care):
- •Left ventricular ejection fraction (LVEF) > 50%;
- •ALT≤ 2.5 × ULN, AST ≤ 2.5 × ULN, total bilirubin ≤ 2 × ULN;
- •Endogenous creatinine clearance ≥ 30 mL/min (creatinine clearance calculated using the Cockcroft-Gault formula);
- •Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN and prothrombin time (PT) ≤ 1.5 × ULN.
排除标准
- •The participant has any serious illness, laboratory abnormality, or psychiatric disorder that may impair the ability to receive or tolerate planned trial treatment; or the investigator judges that the participant's participation in the clinical trial is not in his/her best interest (e.g.,compromised health), or may hinder, limit, or confound protocol-specific Assessments.
- •Participants were diagnosed with acute promyelocytic leukemia (APL),BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase),secondary AML (other than MDS), 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 CD
- •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.
- •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.
研究组 & 干预措施
CAR-T cells# chimeric antigen receptor T cells#
Experimental
CT0991 CAR-T cels inffusicn
干预措施: CT0991 CAR-T cells infusicn (Drug)
结局指标
主要结局
MTD and/or dose range
时间窗: Up to 28 days after CAR-T cells infusion
Evaluate Dose limited toxicity and recommended dosage range after CT0991 infusion.
Adverse Events (AE) after CT0991 infusion
时间窗: 12 months after CT0991 infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria.
Dose-limiting toxicity （DLT）
时间窗: Up to 28 days after CAR-T cells infusion.
The DLT is evaluated as the proportion of patients who experienced adverse events related to CT0991 that meet the criteria for DLT events after the first infusion.
次要结局
- Morphologic leukemia-free status (MLFS) and partial response (PR)(12 months after CT0991 infusion)
- Duration of response （DOR)(12 months after CT0991 infusion.)
- Complete response (CR), complete response with partial hematologic recovery (CRh)(12 months after CT0991 infusion.)
- Event-free survival (EFS)(12 months after CT0991 infusion.)
- Overall survival (OS)(12 months after CT0991 infusion.)
- Minimal Residual Disease (MRD) Negative Rate(12 months after CT0991 infusion.)
- Pharmacokinetic parameters of CT0991, including CAR copy number, peak value, AUC (area under the curve), in vivo persistence, etc.(12 months after CT0991 infusion.)
研究者
MEI HENG
Principal Investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
研究点 (1)
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