Phase I/IIa Study of Descartes-25 in Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
This is a Phase I/IIa dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an allogeneic Mesenchymal Stem Cell (Descartes-25) product secreting a bispecific protein and other proteins in patients with Relapsed/Refractory Multiple Myeloma.
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
- •18 years and older'
- •diagnosed with active R/RMM, who have failed 2 lines of treatment
- •have measurable disease
排除标准
- •Patients with active plasma cell leukemia
研究组 & 干预措施
Arm 1: Dose Level 1
Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.
干预措施: Descartes-25 (Drug)
Arm 2: Dose Level 2
Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.
干预措施: Descartes-25 (Drug)
Arm 3: Dose Level 3
Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.
干预措施: Descartes-25 (Drug)
Arm 4: Dose Expansion
In Arm 2, the MTD established in Arm 1 will be administered for 3 28-day cycles to further evaluate the product's safety and preliminary efficacy.
干预措施: Descartes-25 (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 1 Year
Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity.
次要结局
未报告次要终点