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FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06241456.
