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NCT06241456

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

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.

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Interventions

FT825DRUG
FT825 will be administered as an intravenous (IV) infusion at planned dose levels.
FludarabineDRUG
Fludarabine will be administered as an IV infusion at planned dose levels.
CyclophosphamideDRUG
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
BendamustineDRUG
Bendamustine will be administered as an IV infusion at planned dose levels.
DocetaxelDRUG
Docetaxel will be administered as an IV infusion at planned dose levels.
CisplatinDRUG
Cisplatin will be administered as an IV infusion at planned dose levels.
CetuximabDRUG
Cetuximab will be administered as an IV infusion at planned dose levels.

Study Locations

FacilityCityStateCountry
Banner MD Anderson Cancer CenterGilbertArizonaUnited States
University of California San Diego Moores Cancer CenterLa JollaCaliforniaUnited States
Yale New Haven Hospital - Yale Cancer CenterNew HavenConnecticutUnited States
University of Chicago Medical CenterChicagoIllinoisUnited States
Karmanos Cancer InstituteDetroitMichiganUnited States
University of Minnesota Medical SchoolMinneapolisMinnesotaUnited States
Washington University School of MedicineSt LouisMissouriUnited States
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States
Oncology Hematology Care Clinial TrialsCincinnatiOhioUnited States
Ohio State University - Comprehensive Cancer CenterColumbusOhioUnited States
OU Health Stephenson Cancer CenterOklahoma CityOklahomaUnited States
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvaniaUnited States
Sarah Cannon Research Institute (SCRI) - Oncology PartnersNashvilleTennesseeUnited States
The University of Texas MD Anderson Cancer CenterHoustonTexasUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026