A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer

This is an open-label Phase 1/2a study. Once the safety of the BC1 cell line alone has been demonstrated in Phase 1, in Phase 2, patients will be treated with the Bria-OTS regimen (see below) and a clinically available check point inhibitor (CPI). During the monotherapy phase of Phase 1, one patient will be treated intradermally every 2 weeks for 6 weeks (4 doses) with an initial dose of the BC1 cell line. If this dose is tolerated, the next patient will receive an increased dose of BC1. If once again tolerated, the third patient will receive a further dose increase of the BC1. Once at least

Trial Details

NCT ID
NCT06471673
Phase
PHASE1 / PHASE2
Sponsor
BriaCell Therapeutics Corporation
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • BC1 cell line
  • Bria-OTS regimen and CPI (tislelizumab)
  • Bria-OTS regimen and CPI (tislelizumab) expansion cohort
Locations (sample)
  • Santa Monica, California, United States|34.01949,-118.49138

Key Eligibility Criteria

  • Histological confirmed recurrent metastatic breast cancer which has failed prior
  • therapy defined as:
  • Human epidermal growth factor 2 (EGFR2, HER2) positive tumors must have failed therapy with at least 2 anti-HER2 agents
  • HER2 negative and either ER or PR positive tumors: must be refractory to hormonal therapy and previously treated with at least 2 hormone based targ…

For full eligibility, visit ClinicalTrials.gov.

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