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RECRUITINGPHASE1

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

NCT06241456•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histopathological or cytologically confirmed locally advanced or metastatic cancer that meets protocol-defined criteria
•Disease that is not amenable to curative therapy, with prior therapies defined by specific tumor types
•Contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
•Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to start of first study intervention
•Anticipated life expectancy of at least 3 months

Exclusion Criteria

•Females who are pregnant or breastfeeding
•Evidence of inadequate organ function
•Clinically significant cardiovascular disease
•Known active central nervous system (CNS) involvement by malignancy
•Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment
•Active bacterial, fungal, or viral infections
•Prior receipt of chimeric antigen receptor (CAR) T-cell therapy, other cellular therapy, or a FATE investigational human induced pluripotent stem cell (iPSC) product
•History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out based on imaging at screening
•Any history of Grade ≥3 immune-related AE or Grade ≥2 eye toxicity attributed to prior cancer immunotherapy, other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase
•Active or history of autoimmune disease or immune deficiency
+1 more criteria

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

Key Dates

Start Date

January 5, 2024

Primary Completion Date

May 1, 2029

Completion Date

May 1, 2044

Last Updated

December 9, 2025

Enrollment

351

ESTIMATED participants

Conditions

Advanced Solid Tumor

Interventions

FT825

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

Bendamustine

DRUG

Docetaxel

DRUG

Cisplatin

DRUG

Cetuximab

DRUG

Contacts

Fate Trial Disclosure

CONTACT

858-875-1800 FateTrialDisclosure@fatetherapeutics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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