NCT04502446终止1 期
A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Relapsed or Refractory T or B Cell Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 10
- 主要终点
- Part B (cohort expansion)
研究概览
简要总结
This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.
详细描述
The study may enroll approximately 45 subjects in total.
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
- 18 Years 至 —（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
CTX130
Experimental
Administered by IV infusion following lymphodepleting chemotherapy.
干预措施: CTX130 (Biological)
结局指标
主要结局
Part B (cohort expansion)
时间窗: From CTX130 infusion up to 60 months post-infusion]
Objective response rate
Part A (dose escalation)
时间窗: From CTX130 infusion up to 28 days post-infusion
Incidence of adverse events
次要结局
- Progression Free Survival(From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months)
- Overall Survival(From date of CTX130 until date of death due to any cause, assessed up to 60 months)
研究者
研究点 (10)
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