NCT06241456

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 351 (estimated)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	FT825	FT825 will be administered as an intravenous (IV) infusion at planned dose levels.
DRUG	Fludarabine	Fludarabine will be administered as an IV infusion at planned dose levels.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered as an IV infusion at planned dose levels.
DRUG	Bendamustine	Bendamustine will be administered as an IV infusion at planned dose levels.
DRUG	Docetaxel	Docetaxel will be administered as an IV infusion at planned dose levels.
DRUG	Cisplatin	Cisplatin will be administered as an IV infusion at planned dose levels.
DRUG	Cetuximab	Cetuximab will be administered as an IV infusion at planned dose levels.

Timeline

• Start date: 2024-01-05
• Primary completion: 2029-05-01
• Completion: 2044-05-01
• First posted: 2024-02-05
• Last updated: 2025-12-09

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study