FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in 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.

NCT Number	NCT06241456
Lead Sponsor	Fate Therapeutics
Conditions	Advanced Solid Tumor
Enrollment	351 participants
Start Date	2024-01-05
Primary Completion	2029-05-01 (estimated)
Study Completion	2044-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-09