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

Study Summary

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.

Conditions

Advanced Solid Tumor

Interventions / Drugs

FT825 Fludarabine Cyclophosphamide Bendamustine Docetaxel Cisplatin Cetuximab

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment351 participants

Primary Completion—

Lead SponsorFate Therapeutics

Data Retrieved2026-04-11 04:13:54.903263+00:00

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