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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

Trial Status: Active

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.

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.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

- 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.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Bellicum Pharmaceuticals

  • Primary ID BPX603-201A
  • Secondary IDs NCI-2021-00052
  • Clinicaltrials.gov ID NCT04650451