A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase I/II Clinical Study of Autologous and New Donor CD7 CAR-T Cells for Relapsed or Refractory Mature T-Cell Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD7 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD7 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.
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
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CD7 CAR-T therapy
Enrolled patients were treated with anti-CD7 CAR-T cells, with or without allo-HSCT bridging.
干预措施: CD7 CAR-T cells infusion (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: 21 days
Incidence and type of dose-limiting toxicity(DLT) within 21 days of CD7 CAR-T infusion.
Adverse events (AEs)
时间窗: 21 days
Total number, incidence and severity of adverse events (AEs) within 21 days of CD7 CAR-T infusion.
次要结局
- Objective Response Rate (ORR)(21, 90 days)
- Duration of response (DOR)(up to 2 years)
研究者
Jing Pan
Director of the department of Immunotherapy for Hematopoietic Malignancies
Beijing GoBroad Hospital