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FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
Sponsor: Fate Therapeutics
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
Conditions
Interventions
FT825
FT825 will be administered as an intravenous (IV) infusion at planned dose levels.
Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.
Docetaxel
Docetaxel will be administered as an IV infusion at planned dose levels.
Cisplatin
Cisplatin will be administered as an IV infusion at planned dose levels.
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