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FT825/ONO-8250 for Advanced Solid Tumors

This study is testing a new treatment called FT825 (also known as ONO-8250), which is a type of CAR-T cell therapy, with or without other antibody treatments. It's for people aged 18 and older with advanced solid tumors that are HER2-positive or other types of advanced solid tumors that are no longer responding to standard treatments. The main goal is to see how safe FT825 is and what side effects it might cause. Researchers will also look at how well it works against the cancer. You would receive FT825 and other chemotherapy drugs like Fludarabine, Cyclophosphamide, Bendamustine, or Docetaxel through an IV (into a vein). The study plans to enroll up to 351 participants.

Study design
This is a Phase 1 interventional study designed to evaluate the safety and activity of FT825. It will involve a dose-escalation stage followed by an expansion stage, with a planned enrollment of 351 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events (side effects) for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06241456

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Fate Therapeutics
~351 participants
Updated 2025-12-09 on ClinicalTrials.gov
What's tested:FT825FludarabineCyclophosphamideBendamustineDocetaxelCisplatin

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with dose limiting toxicities (DLTs)
Measured over Up to approximately 29 days
+2 more outcomes measured

Conditions

Advanced Solid Tumor

Explore related trials

Solid NeoplasmERBB2 Gene

Where it's being run

14 sites across 13 states
Ohio2
Arizona1
California1
Connecticut1
Illinois1
Michigan1
Minnesota1
Missouri1

Study leadership

  • Study Director · STUDY_DIRECTOR · Fate Therapeutics

Who to contact

Fate Trial Disclosure
[email protected]
858-875-1800
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants with dose limiting toxicities (DLTs)Up to approximately 29 days

    The number of participants with DLTs will be reported.

  • Number of participants with treatment-emergent adverse events (TEAEs)Up to approximately 2 years

    The number of participants with TEAEs will be reported.

  • Severity of AEsUp to approximately 2 years

    Severity of AEs will be determined according to appropriate rating scales for the type of event reported.