Clinical trial · Interventional
Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to a Dose Limiting Toxicity in another sister trial with same technology.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER-2 Gene Amplification | — | UNRESOLVED | — |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| HER2-positive Gastric Cancer | HER2-Positive Gastric Adenocarcinoma | ALIAS | 0.90 |
| HER-2 Protein Overexpression | — | UNRESOLVED | — |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chimeric antigen receptor (CAR) T cell therapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HER2-targeted dual-switch CAR-T cells
- description
- Subjects will receive one dose of BPX-603 on Day 1, followed by rimiducid IV infusion weekly (as tolerated) starting on Day 8 and continued until treatment discontinuation criteria are met.
- interventionNames
- Biological: chimeric antigen receptor (CAR) T cell therapy
Primary outcomes (2)
- measure
- Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of BPX-603
- timeFrame
- 35 days from time of BPX-603 infusion
- description
- Dose limiting toxicities are defined as BPX-603-related adverse events.
- measure
- Maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)
- timeFrame
- through Phase 1 completion, up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available