A Phase 1/2, Open-label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX131) in Adult Subjects With Relapsed or Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 7
- 主要终点
- Phase 2 (Cohort Expansion): Objective response rate (ORR)
研究概览
简要总结
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.
详细描述
An open-label, multi-center Phase 1/2 study of CTX131 in subjects with relapsed/refractory solid tumors. CTX131 is an is allogeneic CD70- directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).
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
- •Age ≥18 years.
- •Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, esophageal carcinoma, and malignant pleural mesothelioma.
- •Eastern Cooperative Oncology Group performance status 0 or
- •Adequate renal, liver, cardiac and pulmonary organ function.
- •Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX131 infusion.
排除标准
- •Prior treatment with anti-CD70 targeting agents
- •History of certain central nervous system (CNS), cardiac or pulmonary conditions.
- •Presence of uncontrolled bacterial, viral, or fungal infection.
- •Active HIV, hepatitis B virus or hepatitis C virus infection.
- •Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
CTX131
Administered by IV infusion following lymphodepleting chemotherapy.
干预措施: CTX131 (Biological)
结局指标
主要结局
Phase 2 (Cohort Expansion): Objective response rate (ORR)
时间窗: From CTX131 infusion up to 60 months post-infusion
ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to appropriate response evaluation criteria for each disease histology
Phase 1 (Dose Escalation): Incidence of adverse events
时间窗: From CTX131 infusion up to 28 days post-infusion
Defined as dose-limiting toxicities
次要结局
未报告次要终点