A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Diffuse Non-Hodgkin Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Safety of CNCT19 therapy: CTCAE v5.0
研究概览
简要总结
This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of CNCT19 in adult patients with relapsed or refractory diffuse Non-Hodgkin lymphoma.
详细描述
This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of CNCT19 in adult patients with relapsed or refractory diffuse Non-Hodgkin lymphoma. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation & Lymphodepleting Chemotherapy), Treatment and Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CNCT19 cell infusion.
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 70 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
Safety of CNCT19 therapy: CTCAE v5.0
时间窗: 24 months
Safety measures include adverse events as assessed by CTCAE v5.0.
Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D)
时间窗: 28 days
Determine the MTD and DLT of CNCT19 in the Treatment and recommend the dose for Phase II study.
次要结局
- Best Overall Response (BOR)(24 months)
- Progression-free survival (RFS)(24 months)
- Duration of remission (DOR)(24 months)
- Time to initial Response (TTR)(6 months)
- Overall survival (OS)(24 months)
- Overall Remission Rate (ORR), which includes Complete Remission (CR) and Partial Remission (PR)(6 months)