Infusion of CD19-Specific Chimeric Antigen Receptor T-cells Produced by Rapid Personalized Manufacture for Patients With Advanced Lymphoid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Maximun Tolerated Dose (MTD) of the RPM CD19- mbIL15-CAR-T
研究概览
简要总结
This is an open-label Phase 1 study to determine the feasibility, safety, and the recommended maximum tolerated Dose (MTD) of a single infusion of RPM CD19 mbIL15 CAR-T cells for adult patients. Approximately 24 subjects will be enrolled and it is anticipated approximately 16 subjects will be infused at the varied doses of T cells.
详细描述
This is an open-label Phase 1 study to determine the feasibility, safety, and the recommended maximum tolerated Dose (MTD) of a single infusion of RPM CD19 mbIL15 CAR-T cells for adult patients. Approximately 24 subjects will be enrolled and it is anticipated approximately 16 subjects will be infused at the varied doses of T cells.
This study will very rapidly administer T cells that are genetically modified by electroporation using DNA plasmids from the SB system to co-express CD19RCD8CD28 (the CAR), mbIL15, and HER1t. The presence of mbIL15 may allow for reduced doses of CAR-T cells to be infused to reduce the risk for adverse events, such as cytokine release syndrome (CRS).
The key features of study design are listed below.
- Uncontrolled
- Blinding: open-label
- Randomized: no
- Duration of treatment: single infusion within day
- Titration: none
- Single center, Taiwan
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
- 20 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
结局指标
主要结局
Maximun Tolerated Dose (MTD) of the RPM CD19- mbIL15-CAR-T
时间窗: within 4 weeks after infusion
MTD is the highest dose at which no more than 1 of 6 patients experiences a dose limiting toxicity.
次要结局
- Feasibility of the product manufacturing process(day 0 to month 12)
- Adverse events related to treatment(day 0 to month 12)
- Persistence of infused T cells(day 0 to month 12)
- Safety Switch Function(day 0 to month 12)
- Immunogenicity(day 0 to month 12)
- Cytokine Profile(day 0 to month 12)
- Homing ability of the infused T-cells(day 0 to month 12)
- Disease response after T cell infusion(day 0 to month 12)
- Progression-Free Survival(day 0 to month 12)
- Overall Survival(day 0 to month 12)
- Emergence of CD19neg malignant B cells(day 0 to month 12)