NCT04650451暂停1 期
A Phase 1/2, Open-Label, Multicenter, Non-Randomized, Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) In Subjects With Previously Treated Advanced HER2-Positive Solid Tumors
Bellicum Pharmaceuticals14 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2020年12月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 220
- 试验地点
- 14
- 主要终点
- Maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)
研究概览
简要总结
This is a Phase 1/2, open-label, multicenter, non-randomized study to investigate the safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells, BPX-603, administered with rimiducid to subjects with previously treated, locally advanced or metastatic solid tumors which are HER2 amplified/overexpressed.
详细描述
- Phase 1: Cell dose escalation to identify the maximum dose of BPX-603 administered without or with rimiducid. The first subject in each dose cohort will receive BPX-603 alone (without rimiducid) in order to assess safety of the CAR-T monotherapy.
- Phase 2: Indication-specific dose expansion to assess the safety, pharmacodynamics (including BPX-603 persistence and response to temsirolimus as applicable), and clinical activity at the recommended dose for expansion (RDE) identified in Phase 1 in various HER2+ solid tumors.
- During Phase 1 or 2, temsirolimus (single IV dose at 25 mg) may be administered following BPX-603 infusion in response to treatment-emergent toxicity in order to activate the iRC9 safety switch.
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
- •Documented evidence of HER2 amplification/overexpression by local testing.
- •Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic HER2+ solid tumor malignancy for which standard treatment is no longer effective, does not exist, or subject is ineligible.
- •Subjects with a solid tumor malignancy for which HER2-targeted therapy is approved as a standard treatment (e.g., breast, gastric cancers) must have received prior treatment with approved HER2-directed therapy.
- •Measurable disease (at least one target lesion) per RECIST v1.
- •Life expectancy > 12 weeks.
- •Adequate organ function.
排除标准
- •Symptomatic, untreated, or actively progressing central nervous system metastases.
- •Prior CAR T cell or other genetically-modified T cell therapy.
- •Impaired cardiac function or clinically significant cardiac disease.
- •Symptomatic intrinsic lung disease or those with extensive tumor involvement of the lungs.
- •Severe intercurrent infection.
- •Pregnant or breastfeeding.
- •Known HIV positivity.
结局指标
主要结局
Maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)
时间窗: through Phase 1 completion, up to 2 years
Identify the optimal dose of BPX-603 for Phase 2.
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of BPX-603
时间窗: 35 days from time of BPX-603 infusion
Dose limiting toxicities are defined as BPX-603-related adverse events.
次要结局
- Persistence of HER2-CAR T cells (cell counts)(measured over time from baseline through study completion, up to 5 years)
- Expansion of HER2-CAR T cells (vector copy number)(measured over time from baseline through study completion, up to 5 years)
- Antitumor activity of BPX-603(through study completion, up to 5 years)
研究者
研究点 (14)
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