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

  • STATUS
    Recruiting
  • End date
    Jan 2, 2025
  • participants needed
    220
  • sponsor
    Bellicum Pharmaceuticals
Updated on 3 May 2021

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.

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: 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.

Details
Condition HER2 Positive Breast Cancer, HER2 Positive Gastric Cancer, her2/neu-positive breast cancer, her2-positive breast cancer, HER-2 Gene Amplification, HER-2 Protein Overexpression, Solid Tumor, Adult, HER-2 Gene Amplification, HER-2 Protein Overexpression, Solid Tumor, Adult, HER-2 Gene Amplification, HER-2 Protein Overexpression, Solid Tumor, Adult, HER-2 Gene Amplification, HER-2 Protein Overexpression, Solid Tumor, Adult, HER-2 Gene Amplification, HER-2 Protein Overexpression, Solid Tumor, Adult, HER-2 Gene Amplification, HER-2 Protein Overexpression, Solid Tumor, Adult, HER-2 Gene Amplification, HER-2 Protein Overexpression, Solid Tumor, Adult
Treatment chimeric antigen receptor (CAR) T cell therapy
Clinical Study IdentifierNCT04650451
SponsorBellicum Pharmaceuticals
Last Modified on3 May 2021

Eligibility

Yes No Not Sure

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
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