Trials / Suspended
SuspendedNCT04650451
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
- Status
- Suspended
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- Sponsor
- Bellicum Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
* 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.
Conditions
- HER-2 Gene Amplification
- HER2-positive Gastric Cancer
- HER2-positive Breast Cancer
- HER-2 Protein Overexpression
- Solid Tumor, Adult
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | chimeric antigen receptor (CAR) T cell therapy | HER2-targeted dual-switch CAR-T cells |
Timeline
- Start date
- 2020-12-07
- Primary completion
- 2025-12-31
- Completion
- 2027-01-02
- First posted
- 2020-12-02
- Last updated
- 2023-04-20
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04650451. Inclusion in this directory is not an endorsement.