NCT03631576Unknown2 期
CD123/CLL1 CAR-T Cell Therapy for Relapsed and Refractory Acute Myeloid Leukemia
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年8月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Leukemia free survival
研究概览
简要总结
The treatment options for relapse/refractory B-cell acute myeloid leukemia(AML)are limited.CD123/CLL1 CAR-T Cells may have a permanent anti-tumor effect and became very attractive. This study aims to assess the safety and toxicity of CD123/CLL1 CAR-T Cells to patients with relapse/refractory AML.
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
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Aged < 70 years
- •Patients with relapsed/refractory AML
- •Cardiac: Left ventricular ejection fraction ≥ 50%
- •Adequate renal and hepatic function
- •Performance status: Karnofsky ≥ 70%
排除标准
- •Pregnant or lactating females.
- •Any co-morbidity precluding the administration of CD123/CLL1 CAR-T Cells.
结局指标
主要结局
Leukemia free survival
时间窗: 1 year
次要结局
- Adverse events that are related to treatment(1 year)
研究者
Jianda Hu
Director of the department of Hematology
Fujian Medical University
研究点 (1)
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