A Phase 1/2 Dose-Finding Study to Evaluate the Safety, Feasibility, and Activity of BPX-701, a Controllable PRAME T-Cell Receptor Therapy, in HLA-A2+ Subjects With AML, Previously Treated MDS, or Metastatic Uveal Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Part 1 Arm 1: Dose-limiting Toxicity
研究概览
简要总结
The purpose of this study is to evaluate the safety and activity of BPX-701 in participants with relapsed AML, previously treated MDS, or metastatic uveal melanoma expressing high levels of PReferentially expressed Antigen in MElanoma (PRAME). Participants' T cells are modified to recognize and target the PRAME tumor marker on cancer cells.
详细描述
The goal of this study is to characterize the safety, feasibility, and clinical activity of BPX-701, a genetically modified autologous T cell product incorporating an HLA-A2-restricted PRAME-directed TCR and a rimiducid-inducible safety switch, when administered to subjects with relapsed AML, previously treated MDS, or metastatic uveal melanoma.
The study will be comprised of multiple parts:
Part 1 (Phase 1): Cell dose escalation to identify the maximum dose of BPX-701 T cells (escalating doses from 1.25 x 10E6 cells/kg up to 5.0 x 10E6 cells/kg to be explored) Parts 2 and 3 (Phase 2): Dose expansion to assess the safety, pharmacodynamics (including BPX-701 T cell persistence and response to rimiducid as applicable), and clinical activity at the recommended dose identified in Part 1 During Parts 1, 2, or 3, rimiducid may be administered following BPX-701 T cell infusion in response to uncontrollable, treatment-emergent toxicity
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
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
Arm 1 Does Escalation
Participants with relapsed AML or previously treated MDS will receive an intravenous infusion of BPX-701. Dose escalation of BPX-701 will continue until the recommended cell dose level is reached.
Rimiducid may be administered in response to treatment-related toxicity.
干预措施: BPX-701 (Biological)
Arm 1 Does Escalation
Participants with relapsed AML or previously treated MDS will receive an intravenous infusion of BPX-701. Dose escalation of BPX-701 will continue until the recommended cell dose level is reached.
Rimiducid may be administered in response to treatment-related toxicity.
干预措施: Rimiducid (Drug)
Arm 2 Dose Escalation
Participants with metastatic uveal melanoma will receive an intravenous infusion of BPX-701. Dose escalation of BPX-701 will continue until the recommended cell dose level is reached.
Rimiducid may be administered in response to treatment-related toxicity.
干预措施: BPX-701 (Biological)
Arm 2 Dose Escalation
Participants with metastatic uveal melanoma will receive an intravenous infusion of BPX-701. Dose escalation of BPX-701 will continue until the recommended cell dose level is reached.
Rimiducid may be administered in response to treatment-related toxicity.
干预措施: Rimiducid (Drug)
Arm 1 Part 2 Dose Expansion
Participants with relapsed AML or previously treated MDS will receive an intravenous infusion of BPX-701 at the recommended cell dose level.
Rimiducid may be administered in response to treatment-related toxicity.
干预措施: BPX-701 (Biological)
Arm 1 Part 2 Dose Expansion
Participants with relapsed AML or previously treated MDS will receive an intravenous infusion of BPX-701 at the recommended cell dose level.
Rimiducid may be administered in response to treatment-related toxicity.
干预措施: Rimiducid (Drug)
Arm 2 Part 2 Dose Expansion
Participants with metastatic uveal melanoma will receive an intravenous infusion of BPX-701 at the recommended cell dose level.
Rimiducid may be administered in response to treatment-related toxicity.
干预措施: BPX-701 (Biological)
Arm 2 Part 2 Dose Expansion
Participants with metastatic uveal melanoma will receive an intravenous infusion of BPX-701 at the recommended cell dose level.
Rimiducid may be administered in response to treatment-related toxicity.
干预措施: Rimiducid (Drug)
结局指标
主要结局
Part 1 Arm 1: Dose-limiting Toxicity
时间窗: 28 days after BPX-701 infusion
Incidence of dose limiting-toxicity (DLT)
Part 1 Arm 1: Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
时间窗: 15 months
Number of participants with AEs and SAEs assessed for severity using CTCAE
次要结局
未报告次要终点