NCT05105867招募中早期 1 期
A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年9月29日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicities
研究概览
简要总结
It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.
详细描述
The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1；
- •Expected survival time ≥12 weeks;
- •Adequate hematological, renal and liver function;
- •Subjects understand and voluntarily sign the informed consent form.
排除标准
- •Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ;
- •Cyclophosphamide or fludarabine is contraindicated for subjects ;
- •Active central nervous system (CNS) involvement by malignancy；
- •Active infection.
结局指标
主要结局
Dose Limiting Toxicities
时间窗: Up to 4 weeks after CAR-T infusion
Incidence of dose-limiting toxicities as protocol-defined
次要结局
- Objective response rate (ORR)(At 4,12,24 weeks after CAR-T infusion)
研究者
研究点 (1)
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