A Phase 1 Dose-Escalation and Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Wugen, Inc.
- 入组人数
- 28
- 试验地点
- 12
- 主要终点
- Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5
研究概览
简要总结
The purpose of this study is to evaluate the safety, recommended dose, and preliminary anti-tumor activity of WU-CART-007 in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL).
详细描述
This is a first-in-human, multicenter, Phase 1, single-arm study in patients with R/R T-ALL/T-LBL who have exhausted other treatment options. The study evaluates dose escalation and dose expansion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（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
WU-CART-007
A CD7-directed chimeric antigen receptor (CAR) T-cell product.
A single IV infusion of WU-CART-007 Cells on Day 1 after lymphodepletion
干预措施: WU-CART-007 (Biological)
结局指标
主要结局
Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5
时间窗: 24 months
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until end of study visit
Maximum Tolerated Dose (MTD)
时间窗: up to 28 days from first dose
Maximum tolerated or administered dose of WU-CART-007
次要结局
未报告次要终点