Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors
NCT04650451 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2023-04-20
Summary
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
- HER-2 Gene Amplification
- HER2-positive Gastric Cancer
- HER2-positive Breast Cancer
- HER-2 Protein Overexpression
- Solid Tumor, Adult
Interventions
- BIOLOGICAL
-
chimeric antigen receptor (CAR) T cell therapy
HER2-targeted dual-switch CAR-T cells
Sponsors & Collaborators
-
Bellicum Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-07
- Primary Completion
- 2025-12-31
- Completion
- 2027-01-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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