NCT04933825Unknown不适用
An Exploratory,Open-label,and Single Center Study to Evaluate the Safety and Efficacy of ET-02 in Patients With Relapsed or Refractory B-cell Malignancies(NHL/ALL).
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of CD19-UCART in patients with r/r B-cell hematological malignancies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients volunteer to participate in the study and sign the ICF;
- •Male or female aged≥18 years old；
- •Patient with relapsed or refractory CD19 positive B-ALL orNHL，as evidenced by 2 or more lines of prior therapy ;
- •Estimated life expectancy≥12 weeks ;
- •ECOG performance status ≤1;
- •Adequate organ function.
排除标准
- •Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy；
- •History of central nervous system (CNS) involvement by malignancy；
- •Women who are pregnant or breastfeeding；
- •Any situations that may increase the risk of patients or interfere with the results of study，which judged by investigator.
研究组 & 干预措施
Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design.
Experimental
干预措施: ET-02 (Biological)
结局指标
主要结局
Incidence of adverse events
时间窗: up to 2 years after lymphodepleting chemotherapy
Adverse events assessed according to NCI-CTCAE v5.0 criteria
次要结局
未报告次要终点
研究者
研究点 (1)
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Unknown
早期 1 期
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