CLINICAL TRIAL / NCT06241456

FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, with or Without Monoclonal Antibodies in Advanced Solid Tumors

  • Interventional
  • Active
  • NCT06241456

A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, with or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors

This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.