NCT04766840Unknown1 期
A Study to Evaluate the Safety and Efficacy of Donor-derived CAR-T Cells in the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia
Beijing Immunochina Medical Science & Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
This is a clinical study to evaluate the safety and efficacy of donor-derived CAR-T cells in the treatment of patients with relapsed or refractory acute myeloid leukemia in China.
详细描述
This is a single-center, single-arm, open-label study. This study is planned to enroll about 9 subjects with relapsed or refractory acute myelogenous leukemia and 9 matched donors for leukapheresis and CAR-T cells manufacture. Donor-derived CAR-T cells were then infused intravenously into subjects, in a dose-escalating 3+3 design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory or relapsed AML patients.
- •Have found an appropriate matched donor for CAR-T cells manufacturing.
- •Patients must have evaluable evidence of disease.
- •Age ≥ 18 years; Expected survival is more than 3 months.
- •ECOG score 0-2 points.
- •Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up.
- •Adequet liver, kidney, heart and lung function.
排除标准
- •Confirmed acute promyelocytic leukemia; or recent symptomatic central nervous system leukemia.
- •Patients with graft-versus-host disease requiring the use of immunosuppressive agents; or patients with autoimmune system diseases.
- •Prior use of any gene therapy product.
- •History of epilepsy or other central nervous system diseases.
- •Presence of concurrent active malignancy.
- •Active hepatitis B or C virus, patients with HIV or syphilis infection.
- •Currently participating in or having participated in other drug clinical trials during past 30 days.
- •Active or uncontrolled infection requiring systemic therapy within 14 days prior to enrollment.
- •Other situations not suitable for the study judged by the investigator.
研究组 & 干预措施
IM73 CAR-T
Experimental
Drug: IM73 CAR-T Cells
- Fludarabine
- Cyclophosphamide
干预措施: CAR-T cells (Drug)
结局指标
主要结局
Dose limiting toxicity
时间窗: 28 days
≥ Grade 4 adverse event related to CAR-T cells infusion
次要结局
- Objective response rate(28 days)
研究者
研究点 (1)
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