Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HER-2 Gene Amplification
- HER-2 Protein Overexpression
- HER2 Positive Breast Cancer
- HER2 Positive Gastric Cancer
- Solid Tumor, Adult
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Phase 1: Cell dose escalation to identify the maximum dose of BPX-603 administered without or with rimiducid (fixed dose at 0.4 mg/kg per infusion). 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: Indic...
Phase 1: Cell dose escalation to identify the maximum dose of BPX-603 administered without or with rimiducid (fixed dose at 0.4 mg/kg per infusion). 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.
Tracking Information
- NCT #
- NCT04650451
- Collaborators
- Not Provided
- Investigators
- Not Provided
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