Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM)
研究概览
简要总结
This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1 Descartes-15 with lymphodepletion
Intra-patient dose escalation arm with three dose levels over the course of six infusions of cell product. Patients will receive lymphodepletion prior to initiating cell therapy.
干预措施: Descartes-15 (Drug)
Part 2 Arm 1 Descartes-15 with lymphodepletion
Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will receive lymphodepletion prior to initiating cell therapy.
干预措施: Descartes-15 (Drug)
Part 2 Arm 2 Descartes-15 without lymphodepletion
Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will not receive lymphodepletion prior to initiating cell therapy.
干预措施: Descartes-15 (Drug)
结局指标
主要结局
Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM)
时间窗: Day -60 to Month 12
Results will be descriptive. Safety and tolerability endpoints are adverse events and serious adverse events as proportion of all participants at a given dose level and in the overall study population.
次要结局
- To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival(Day 1 to Month 12)