NCT05371730尚未招募早期 1 期
A Trial to Evaluate the Safety and Efficacy of NK Cells in Subjects With Myelodysplastic Syndromes
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- AE or SAE
研究概览
简要总结
A clinical study to Evaluate the Safety and Efficacy of NK cells in the treatment of Myelodysplastic Syndromes
详细描述
This is a single arm, open-label, single-center pilot study. In this study, 15 patients will be enrolled. The primary purpose is to explore the safety including incidence of adverse events and serious adverse events.The secondary purpose is to explore the efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 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
研究组 & 干预措施
NK cells
Experimental
干预措施: NCR300 (Drug)
结局指标
主要结局
AE or SAE
时间窗: From infusion day 365
The incidence of AE or SAE of NK cells infusion
次要结局
- Objective response rate (ORR)(58 days after initial infusion)
- Bone Marrow Morphology(58 days after initial infusion)
研究者
Xiaoyu Zhu, M.D., Ph.D.
Chief Physician
The First Affiliated Hospital of University of Science and Technology of China
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