NCT04351022Unknown1 期
Pilot Study of the Efficacy and Safety of CD38 Targeted Chimeric Antigen Receptor Engineered T-Cells in the Treatment of CD38 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD38 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD38 positive relapsed or refractory acute myeloid leukemia.
详细描述
The patients will receive infusion of CAR T-cells targeting CD38 to confirm the safety and efficacy of CD38 CAR T-Cells in relapsed or refractory acute myeloid leukemia.
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
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD38 positive relapsed/refractory acute myeloid leukemia
- •age 6-65 years.
- •left ventricular ejection fractions ≥ 0.5 by echocardiography
- •creatinine < 1.6 mg/dL
- •aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal
- •Total bilirubin <2.0 mg/dL
- •karnofsky performance status ≥ 60
- •expected survival time ≥ 3 months (according to investigator's judgement)
排除标准
- •patients are pregnant or lactating
- •uncontrolled active infection
- •class III/IV cardiovascular disability according to the New York Heart Association Classification
- •active hepatitis B or hepatitis C infection
- •patients with HIV infection
- •patients with history of seizure
- •active central nervous system leukemia
结局指标
主要结局
Number of Adverse Events
时间窗: 12 months
Adverse events are evaluated with CTCAE V5.0
次要结局
- Overall response rate (ORR)(2 years)
- Event-free survival (EFS)(2 years)
- Cumulative incidence of relapse(CIR)(2 years)
研究者
研究点 (1)
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