A Phase 1/2 Feasibility, Safety, and Activity Study of PSCA-Specific Chimeric Antigen Receptor Engineered T Cells (BPX-601) in Subjects With Previously Treated Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 13
- 主要终点
- 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-601 CAR-T cells in participants with previously treated advanced solid tumors (prostate) expressing high levels of prostate stem cell antigen (PSCA). Participants' T cells are modified to recognize and target the PSCA tumor marker on cancer cells.
详细描述
Former Sponsor Bellicum Pharmaceuticals
Study ended prior to the start of Phase 2
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
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
- •Metastatic castration-resistant prostate cancer (mCRPC), with progressive disease per PCWG3 criteria during or following the direct prior line of therapy.
- •Measurable disease per RECIST v1.1 at baseline; subjects with mCRPC with bone only metastases must have measurable PSA.
- •Age ≥18 years.
- •Life expectancy > 12 weeks.
- •Adequate organ function.
排除标准
- •Prostate cancer with unstable bone lesions or symptomatic/untreated coagulopathy, or history of > Grade 2 hematuria within the previous 6 months.
- •Prior CAR T cell or other genetically-modified T cell therapy. Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies are allowable.
- •Symptomatic, untreated, or actively progressing central nervous system metastases.
- •Impaired cardiac function or clinically significant cardiac disease.
- •Pregnant or breastfeeding.
- •Participant requires chronic, systemic steroid therapy.
- •Severe intercurrent infection.
- •Known HIV positivity.
研究组 & 干预措施
Arm 1: Phase 1 Dose Escalation
Participants with advanced prostate cancer will receive an intravenous infusion of BPX-601 followed by one or more intravenous infusions of rimiducid. Dose escalation of BPX-601 will continue until the recommended cell dose level is reached.
干预措施: BPX-601 (Biological)
Arm 1: Phase 1 Dose Escalation
Participants with advanced prostate cancer will receive an intravenous infusion of BPX-601 followed by one or more intravenous infusions of rimiducid. Dose escalation of BPX-601 will continue until the recommended cell dose level is reached.
干预措施: Rimiducid (Drug)
Arm 2: Phase 2 Dose Expansion
Participants with advanced prostate cancer will receive an intravenous infusion of BPX-601 at the recommended cell dose level followed by one or more intravenous infusions of rimiducid.
干预措施: BPX-601 (Biological)
Arm 2: Phase 2 Dose Expansion
Participants with advanced prostate cancer will receive an intravenous infusion of BPX-601 at the recommended cell dose level followed by one or more intravenous infusions of rimiducid.
干预措施: Rimiducid (Drug)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: 4 weeks after first rimiducid infusion (i.e., Day 35)
Incidence of dose limiting toxicity
Treatment emergent adverse events (AEs) and serious AEs (SAEs)
时间窗: 180 days after BPX-601 treatment up to 15 years
Number of participants with adverse events (AEs) and serious AEs (SAEs) assessed for severity using NCI CTCAE v4.03
Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
时间窗: through Phase 1 completion, up to 5 years
Identify the optimal dose of BPX-601 with rimiducid for Phase 2
次要结局
- Antitumor activity of BPX-601(From the time of BPX-601 cell infusion until confirmed disease progression or death due to any cause, the start of new anticancer therapy, or withdrawal, whichever comes first, as assessed for up to 5 years after the last subject has been enrolled)
- Pharmacodynamics (PD) of BPX-601(up to 1 year after treatment)