Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of BCMA-CS1 cCAR in Patients With Relapsed and/or Refractory Multiple Myeloma
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
研究概览
简要总结
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CS1 cCAR in patients with relapsed and/or refractory multiple myeloma.
详细描述
BCMA-CS1 cCAR (Compound CAR BCMA-CS1) is a chimeric antigen receptor immunotherapy treatment designed to treat multiple myeloma using two different antigen targets, BCMA (CD269) and CS1 (SLAMF7).
The use of two different targets widely expressed on plasma cells, BCMA and CS1, intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape. BCMA-CS1 cCAR bears two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins BCMA and CS1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis based on the World Health Organization (WHO) 2008
- •Patients have exhausted standard therapeutic options
- •Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
- •Female must be not pregnant during the study
排除标准
- •Prior solid organ transplantation
- •Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- •Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents
结局指标
主要结局
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
时间窗: 2 years
Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
时间窗: 28 days
Type of dose-limiting toxicity (DLT)
时间窗: 28 days
次要结局
- Overall Response Rate (ORR)(1 year)
- Progression-free survival (PFS)(1 year)
- Overall survival(1 year)