An Exploratory Clinical Study on the Safety and Efficacy of Allogeneic CAR-T Cell (RN1201) for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- The incidence and severity of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs)
研究概览
简要总结
This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+/BCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status. The trial assesses overall response and disease control rates, treatment-emergent adverse events, and in vivo behavior of UCAR-T cells.
详细描述
This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+/BCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status.Primary endpoints include treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), pharmacokinetics, and pharmacodynamics of UCAR-T. This study aims to provide initial evidence for the safety and anti-tumor activity of UCAR-T in CD19+/BCMA+ hematologic malignancies.
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 —（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
Allogeneic CAR-T cell therapy
RN1201 cells injection will be infused via intravenously
干预措施: Allogeneic CAR-T (Biological)
结局指标
主要结局
The incidence and severity of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs)
时间窗: DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 12 months post-treatment.
TEAEs and DLTs will be graded according to CTCAE v5.0 and ASTCT consensus criteria
次要结局
- Objective Response Rate (ORR)(Week 4, Month 3, Month 6 and Month 12)
- Disease control rate (DCR)(Week 4, Month 3, Month 6 and Month 12)
- Progression-free survival (PFS)(Week 4, Month 3, Month 6 and Month 12)
- Overall survival (OS)(Week 4, Month 3, Month 6 and Month 12)
- Cmax of RN1201(Up to 12 months)
- Tmax of RN1201(Up to 12 months)
- Cytokines in the peripheral blood after RN1201 infusion(Up to 12 months)
研究者
Lei Fan
Director of lymphoma center
The First Affiliated Hospital with Nanjing Medical University