JY231 Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma/ Leukemia - A Safety, Tolerability, and Efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of adverse events(AE) after infusion
研究概览
简要总结
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma / leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma / leukemia.
详细描述
This open-label, single-arm study is designed to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with relapsed refractory B-cell lymphoma/leukaemia. Upon enrolment, leukapheresis will be performed and patients will receive 3-5 days of fludarabine and cyclophosphamide lymphodepleting therapy followed by an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be evaluated for safety and efficacy for up to 24 months to determine if the disease is under control.
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
JY231 Injection for the Treatment of relapsed or refractory B cell lymphoma/ leukemia
Subjects who meet the Inclusion Criteria will receive intravenous JY231. JY231 infusion will produce in vivo CAR-T cells in the body.
干预措施: JY231 Injection (Drug)
结局指标
主要结局
Incidence of adverse events(AE) after infusion
时间窗: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Maximum Tolerated Dose(MTD)
时间窗: Up to 28 days after infusion
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
次要结局
- Objective Response Rate(Up to 3 months after infusion)
研究者
Yi Zhang
Chief Physician and Professor
The First Affiliated Hospital of Zhengzhou University