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

BPX603-201A

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.

2020-12-07

2025-12-31

2027-01-02

Early phase I

220

Inclusion Criteria: * 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 v1.1. * Life expectancy \> 12 weeks. * ECOG 0-1. * Adequate organ function. Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 220, 'type': 'ESTIMATED'}}

2023-04-20