A Phase I Multi-dose Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) with or Without Recombinant Human Interleukin-2 (rhIL-2) in Adults with Primary or Secondary Acute Myeloid Leukemia (AML) in Morphologic Complete Remission with Minimal Residual Disease (MRD) or Relapsed/refractory (R/R) AML
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 10
- 主要终点
- Number of Participants who experience a Dose-limiting Toxicity (DLT) in Relapsed/Refractory AML patients
研究概览
简要总结
This study will find the maximum tolerated dose or the maximum planned dose of CYNK-001 which contains natural killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating acute myeloid leukemia.
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 80 Years（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
Dose escalation/MTD or MPD determination in Relapsed/Refractory AML patients
Cyclophosphamide + Fludarabine prior to CYNK-001 on Days 0, 7, and 14; CYNK-001 at 3 varying dose levels.
干预措施: CYNK-001 (Biological)
Dose escalation/MTD or MPD determination in MRD positive AML patients
Cyclophosphamide + Fludarabine prior to CYNK-001 on Days 0, 7, and 14; CYNK-001 at 3 varying dose levels.
干预措施: CYNK-001 (Biological)
结局指标
主要结局
Number of Participants who experience a Dose-limiting Toxicity (DLT) in Relapsed/Refractory AML patients
时间窗: Day +28
The number of participants who experience a DLT will be measured.
Number of Participants who experience a Dose-limiting Toxicity (DLT) in MRD positive AML patients
时间窗: Day +28
The number of participants who experience a DLT will be measured.
Determine the Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD) of CYNK-001 in MRD positive AML patients
时间窗: up to 28 days
The maximum dose safely administered for the treatment of patients with AML.
Determine the Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD) of CYNK-001 in Relapsed/Refractory AML patients
时间窗: up to 28 days
The maximum dose safely administered for the treatment of patients with AML.
Frequency and Severity of Adverse Events (AEs)
时间窗: up to 12 months
Frequency and severity of Adverse Events will be evaluated.
次要结局
- Duration of Morphologic Complete Remission (CR)(up to 12 months)
- Duration of MRD Response(up to 12 months)
- Overall Survival (OS)(up to 12 months)
- Time to MRD Response(up to 12 months)
- Progression-free Survival (PFS)(up to 12 months)
- Number Participants who experience Minimal Residual Disease (MRD) Response(up to 12 months)
- Time to Progression (TTP)(up to 12 months)
- Overall Response Rate (ORR)(up to 12 months)
- Duration of Response (DoR)(up to 12 months)