NCT04438083终止1 期
A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Advanced, Relapsed or Refractory Renal Cell Carcinoma With Clear Cell Differentiation
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
- 19
- 试验地点
- 7
- 主要终点
- Part A (dose escalation): Incidence of adverse events
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 renal cell carcinoma.
详细描述
The study may enroll approximately 107subjects 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
- •Age ≥18 years and body weight ≥42 kg.
- •Unresectable or metastatic RCC that has exploited standard of care treatment.
- •Karnofsky performance status (KPS) ≥80%.
- •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 CTX130 infusion.
- •Abbreviated
排除标准
- •Prior treatment with any anti-CD70 targeting agents.
- •Prior treatment with any CAR T cells or any other modified T or natural killer (NK) cells.
- •History of certain central nervous system (CNS), cardiac or pulmonary conditions.
- •Active HIV, hepatitis B virus or hepatitis C virus infection.
- •Previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for >12 months, or any other localized malignancy with low risk of developing into metastatic disease.
- •Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
- •Prior solid organ transplantation or bone marrow transplant.
- •Pregnant or breastfeeding females.
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 A (dose escalation): Incidence of adverse events
时间窗: From CTX130 infusion up to 28 days post-infusion
Adverse events defined as dose-limiting toxicities
Part B (cohort expansion): Objective response rate
时间窗: From CTX130 infusion up to 60 months post-infusion]
Objective response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
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 (7)
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