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Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors


Active: Yes
Cancer Type: Breast Cancer NCT ID: NCT04650451
Trial Phases: Phase I Protocol IDs: BPX603-201A (primary)
NCI-2021-00052
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Bellicum Pharmaceuticals
NCI Full Details: http://clinicaltrials.gov/show/NCT04650451

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.

Objectives

- 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.
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