A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Subjects With Relapsed or Refractory B Cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities
研究概览
简要总结
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.
详细描述
This is an open-label, multi-center Phase 1/2 study of CTX112 in subjects with relapsed/refractory B cell malignancies. CTX112 is an is allogeneic CD19-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.
- •Refractory or relapsed B cell malignancy.
- •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 CTX112 infusion.
排除标准
- •Prior allogeneic hematopoietic stem cell transplant (HSCT).
- •Active or history of central nervous system (CNS) involvement by malignancy.
- •History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
- •Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
- •Active HIV, hepatitis B virus or hepatitis C virus infection.
- •Previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence).
- •Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX112 infusion or with a nonbiological anticancer drug within 14 days prior to CTX112 infusion.
- •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
CTX112
Administered by IV infusion following lymphodepleting chemotherapy.
干预措施: CTX112 (Biological)
结局指标
主要结局
Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities
时间窗: From CTX112 infusion up to 28 days post-infusion
Phase 2 (Cohort Expansion): Objective response rate
时间窗: From CTX112 infusion up to 60 months post-infusion
次要结局
- Duration of Response(From date of first objective response of complete response (CR)/partial response (PR) until date of disease progression or death due to any cause, assessed up to 60 months)
- Duration of Clinical Benefit (DOCB)(From date of first objective response of CR/PR until the relapse or death that followed the last response, assessed up to 60 months)
- Progression Free Survival(From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months)
- Overall Survival(From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months)