NCT04244656终止1 期
A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-BCMA Allogeneic CRISPR-Cas9-Engineered T Cells (CTX120) in Subjects With Relapsed or Refractory Multiple Myeloma
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
- 26
- 试验地点
- 10
- 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 CTX120 in subjects with relapsed or refractory multiple myeloma.
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.
- •Relapsed or refractory multiple myeloma, as defined by IMWG response criteria and treatment with at least 2 prior lines of therapy.
- •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 CTX120 infusion.
排除标准
- •Prior allogeneic stem cell transplant (SCT).
- •Less than 60 days from autologous SCT at time of screening and with unresolved serious complications.
- •Prior treatment with any gene therapy or genetically modified cell therapy, including CAR T cells or natural killer cells, or BCMA-directed therapy.
- •Evidence of direct central nervous system (CNS) involvement by multiple myeloma.
- •History or presence of clinically relevant CNS pathology such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement.
- •Unstable angina, clinically significant arrhythmia, or myocardial infarction within 6 months of enrollment.
- •Active HIV, hepatitis B virus or hepatitis C virus infection.
- •Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years.
- •Use of systemic anti-tumor therapy or investigational agent within 14 days prior to enrollment.
- •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
CTX120
Experimental
Administered by IV infusion following lymphodepleting chemotherapy.
干预措施: CTX120 (Biological)
结局指标
主要结局
Part A (dose escalation): Incidence of adverse events
时间窗: From CTX120 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 CTX120 infusion up to 60 months post-infusion
Objective response rate per International Myeloma Working Group (IMWG) response criteria.
次要结局
- Overall Survival(From date of CTX120 infusion until date of death due to any cause, assessed up to 60 months)
- Progression Free Survival(From date of CTX120 infusion and date of disease progression or death due to any cause, assessed up to 60 months)
研究者
研究点 (10)
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