A Phase I Study of FT576 as Monotherapy and in Combination With Daratumumab in Subjects With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 14
- 主要终点
- Incidence and nature of DLTs within each dose-escalation cohort to determine the MTD or MAD
研究概览
简要总结
This is a Phase I dose-finding study of FT576 as monotherapy and in combination with the monoclonal antibody daratumumab in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
Regimens A-A4
FT576 single dose monotherapy in subjects with r/r MM
干预措施: Cyclophosphamide (Drug)
Regimens A-A4
FT576 single dose monotherapy in subjects with r/r MM
干预措施: Fludarabine (Drug)
Regimens A-A4
FT576 single dose monotherapy in subjects with r/r MM
干预措施: Bendamustine (Drug)
Regimens A-A4
FT576 single dose monotherapy in subjects with r/r MM
干预措施: FT576 (Allogenic CAR NK cells with BCMA expression) (Drug)
Regimen A1
FT576 multiple dose monotherapy in subjects with r/r MM
干预措施: FT576 (Allogenic CAR NK cells with BCMA expression) (Drug)
Regimen A1
FT576 multiple dose monotherapy in subjects with r/r MM
干预措施: Cyclophosphamide (Drug)
Regimen A1
FT576 multiple dose monotherapy in subjects with r/r MM
干预措施: Fludarabine (Drug)
Regimen A1
FT576 multiple dose monotherapy in subjects with r/r MM
干预措施: Bendamustine (Drug)
Regimens B-B4
FT576 single dose in combination with daratumumab in subjects with r/r MM
干预措施: FT576 (Allogenic CAR NK cells with BCMA expression) (Drug)
Regimens B-B4
FT576 single dose in combination with daratumumab in subjects with r/r MM
干预措施: Cyclophosphamide (Drug)
Regimens B-B4
FT576 single dose in combination with daratumumab in subjects with r/r MM
干预措施: Fludarabine (Drug)
Regimens B-B4
FT576 single dose in combination with daratumumab in subjects with r/r MM
干预措施: Daratumumab (Drug)
Regimens B-B4
FT576 single dose in combination with daratumumab in subjects with r/r MM
干预措施: Bendamustine (Drug)
Regimen B1
FT576 multiple dose in combination with daratumumab in subjects with r/r MM
干预措施: FT576 (Allogenic CAR NK cells with BCMA expression) (Drug)
Regimen B1
FT576 multiple dose in combination with daratumumab in subjects with r/r MM
干预措施: Cyclophosphamide (Drug)
Regimen B1
FT576 multiple dose in combination with daratumumab in subjects with r/r MM
干预措施: Fludarabine (Drug)
Regimen B1
FT576 multiple dose in combination with daratumumab in subjects with r/r MM
干预措施: Daratumumab (Drug)
Regimen B1
FT576 multiple dose in combination with daratumumab in subjects with r/r MM
干预措施: Bendamustine (Drug)
结局指标
主要结局
Incidence and nature of DLTs within each dose-escalation cohort to determine the MTD or MAD
时间窗: Cycle 1 Day -5 to Day 29 for Regimen A and A1; Cycle 1 Day -11 to Day 29 (each cycle is 40 days) for Regimen B and B1
Incidence, nature, and severity of adverse events
时间窗: Cycle 1 Day -5 to Day 29 for Regimen A and A1; Cycle 1 Day -11 to Day 29 (each cycle is 40 days) for Regimen B and B1
Determine the RP2D which will be based on the overall safety and anti-tumor activity among the dose escalation and dose expansion cohorts
时间窗: From FPI to LPI's end of Cycle 1 study treatment (End of cycle is Day 29 from Day 1 FT576 infusion)
次要结局
- Progression-free survival (PFS)(Up to 15 years)
- Relapse-free survival (RFS) from complete response (CR)(Up to 15 years)
- Pharmacokinetics (PK) of FT576(From Baseline to PTFU visit of last cycle on the study treatment (End of cycle is Day 29 from Day 1 FT576 infusion of this cycle))
- Objective response rate (ORR)(From baseline tumor assessment up to approximately 2 years after last dose of FT576)
- Overall survival (OS)(Up to 15 years)
- Duration of response (DOR)(Up to 15 years)