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


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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.

Targeted Conditions

Study Overview

Start Date
January 5, 2024
Completion Date
May 1, 2044
Date Posted
February 5, 2024
Accepts Healthy Volunteers?


Full Address
University of Minnesota Medical School
Minneapolis, Minnesota 55455, United States

Sarah Cannon Research Institute (SCRI) - Nashville
Nashville, Tennessee 37203, United States

The University of Texas MD Anderson Cancer Center
Houston, Texas 77030, United States


Minimum Age (years)
Eligibility Criteria
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
Receipt of an allograft organ transplant

Study Contact Info

Study Contact Name
Fate Trial Disclosure
Study Contact Phone

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Other Details

FDA Regulated Drug?
FDA Regulated Device?
NCTid (if applicable)