A Phase 1 Study of PBCAR19B in Participants With CD19-expressing Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 7
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is a Phase 1, nonrandomized, open-label, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR19B in adult study participants with CD-19 expressing malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Relapsed or refractory CD19+ expressing malignancies
- •At least 2 prior regimens per Standard of Care
排除标准
- •No history of active CNS involvement
研究组 & 干预措施
Dose Level 1
In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL).
Route of Administration: Intravenous injection/infusion.
干预措施: PBCAR19B (Genetic)
Dose Level 2
In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL).
Route of Administration: Intravenous injection/infusion.
干预措施: PBCAR19B (Genetic)
Dose Level 3
In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL).
Route of Administration: Intravenous injection/infusion.
干预措施: PBCAR19B (Genetic)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: Day 1 - Day 28
To determine the maximum tolerated dose (MTD)
Number of participants with Dose Limiting Toxicity(ies)
时间窗: 1 year
To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0.
次要结局
未报告次要终点