An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Incidence of Dose-Limiting Toxicity (DLT)
研究概览
简要总结
A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells in patients with autoimmune diseases. 36-72 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study was to evaluate the safety and feasibility of CD19 CAR-NK cells for the treatment of patients with autoimmune diseases. The secondary objective is to evaluate the efficacy of CD19 CAR-NK cells in patients with autoimmune diseases.
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 65 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
CD19 CAR NK cells
干预措施: anti-CD19 CAR NK cells (Biological)
结局指标
主要结局
Incidence of Dose-Limiting Toxicity (DLT)
时间窗: up to 48 weeks after infusion
To characterize the safety of CD19 CAR NK Cells (KN5501) for Relapsed/Refractory autoimmune diseases
Incidence of Treatment Emergent Adverse Events (TEAEs)
时间窗: up to 48 weeks after infusion
To characterize the safety of CD19 CAR NK Cells (KN5501) for Relapsed/Refractory autoimmune diseases
次要结局
- The overall response rate (ORR)(Time Frame: 1, 3, 6, 12 and 12 months after infusion)
- Disease control rate (DCR)(Time Frame: 1, 3, 6, 12 and 12 months after infusion)