Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment-Related Adverse Events
研究概览
简要总结
This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-11 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Active multiple myeloma that is refractory after at least 2 prior lines of therapy;
- •measurable disease;
- •adequate vital organ function; and
- •no active infection.
排除标准
- 未提供
研究组 & 干预措施
Dose Level 1
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14
干预措施: Fludarabine (Drug)
Dose Level 1
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14
干预措施: Descartes-11 (Biological)
Dose Level 1
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14
干预措施: Cyclophosphamide (Drug)
Dose Level 2
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14
干预措施: Descartes-11 (Biological)
Dose Level 2
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14
干预措施: Fludarabine (Drug)
Dose Level 2
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14
干预措施: Cyclophosphamide (Drug)
Dose Level 3
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14
干预措施: Descartes-11 (Biological)
Dose Level 3
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14
干预措施: Fludarabine (Drug)
Dose Level 3
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14
干预措施: Cyclophosphamide (Drug)
Dose Level 4 A
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21
干预措施: Descartes-11 (Biological)
Dose Level 4 A
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21
干预措施: Fludarabine (Drug)
Dose Level 4 A
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21
干预措施: Cyclophosphamide (Drug)
Dose Level 4B
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21
干预措施: Descartes-11 (Biological)
Dose Level 4B
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21
干预措施: Fludarabine (Drug)
Dose Level 4B
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21
干预措施: Cyclophosphamide (Drug)
Dose Level 4C
Participants were not administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3
Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4, 7,10,14,21
干预措施: Descartes-11 (Biological)
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events
时间窗: Time Frame: 21 days
Determine the safety of Descartes-11 in patients with relapsed/refractory multiple myeloma
次要结局
- Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria(Disease assessment is on Day 21 (or at least 14 days after first Descartes-11 infusion))