Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06241456
PHASE1

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

Sponsor: Fate Therapeutics

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

351

Start Date

2024-01-05

Completion Date

2044-05-01

Last Updated

2025-12-09

Healthy Volunteers

No

Interventions

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.

Locations (14)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

University of California San Diego Moores Cancer Center

La Jolla, California, United States

Yale New Haven Hospital - Yale Cancer Center

New Haven, Connecticut, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University of Minnesota Medical School

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Oncology Hematology Care Clinial Trials

Cincinnati, Ohio, United States

Ohio State University - Comprehensive Cancer Center

Columbus, Ohio, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute (SCRI) - Oncology Partners

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States