NCT04309084进行中（未招募）1 期
A Phase I Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK 001) in Multiple Myeloma Patients Following Autologous Stem Cell Transplant in the Front-line Setting.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 29
- 试验地点
- 8
- 主要终点
- Dose-Limiting Toxicity (DLT)
研究概览
简要总结
This study will find the maximum tolerated dose (MTD) of CYNK-001 which contain NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given post Autologous Stem Cell Transplant (ASCT). The safety of this treatment will be evaluated, and researchers will want to learn if NK cells will help in treating Multiple Myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 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
结局指标
主要结局
Dose-Limiting Toxicity (DLT)
时间窗: Up to 28 days
Safety Assessment of Dose-Limiting Toxicity (DLT)
Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD)
时间窗: Up to 28 days
Safety Assessment of MTD OR MPD
Rate of Minimal Residual Disease (MRD) Negativity
时间窗: Day 90-100
Efficacy Assessment of MRD
Adverse Events (AE)
时间窗: Up to 12 months
Safety Assessment of AE's
次要结局
- International Myeloma Working Group (IMWG) response(up to 12 months)
- Progression-free survival(up to 12 months)
- time to progression(up to 12 months)
- overall survival(up to 12 months)
- Quality of life questionnaire(up to 12 months)
- Minimal Residual Disease (MRD) Response(Day 90-100)
- Time to MRD Response(up to 12 months)
- duration of clinical response(up to 12 months)
研究者
研究点 (8)
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