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Recruiting NCT06241456

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

Phase I Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FT825, Fludarabine, Cyclophosphamide, Bendamustine.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug FT825
    FT825 will be administered as an intravenous (IV) infusion at planned dose levels.
  • Drug Fludarabine
    Fludarabine will be administered as an IV infusion at planned dose levels.
  • Drug Cyclophosphamide
    Cyclophosphamide will be administered as an IV infusion at planned dose levels.
  • Drug Bendamustine
    Bendamustine will be administered as an IV infusion at planned dose levels.
  • Drug Docetaxel
    Docetaxel will be administered as an IV infusion at planned dose levels.
  • Drug Cisplatin
    Cisplatin will be administered as an IV infusion at planned dose levels.
  • Drug Cetuximab
    Cetuximab will be administered as an IV infusion at planned dose levels.

Primary outcome measures

  • Number of participants with dose limiting toxicities (DLTs) [Time frame: Up to approximately 29 days]
  • Number of participants with treatment-emergent adverse events (TEAEs) [Time frame: Up to approximately 2 years]
  • Severity of AEs [Time frame: Up to approximately 2 years]
Secondary outcome measures (5)
  • Investigator-Assessed Overall Response Rate (ORR) [Time frame: Up to approximately 2 years]
  • Investigator-Assessed Duration of Response (DOR) [Time frame: Up to approximately 2 years]
  • Progression-Free Survival (PFS) [Time frame: Up to approximately 2 years]
  • Overall Survival (OS) [Time frame: Up to approximately 2 years]
  • Plasma Concentration of FT825 [Time frame: At designated time points up to approximately 56 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 14 centers
  • Banner MD Anderson Cancer Center — Gilbert
  • University of California San Diego Moores Cancer Center — La Jolla
  • Yale New Haven Hospital - Yale Cancer Center — New Haven
  • University of Chicago Medical Center — Chicago
  • Karmanos Cancer Institute — Detroit
  • University of Minnesota Medical School — Minneapolis
  • Washington University School of Medicine — St Louis
  • Memorial Sloan Kettering Cancer Center — New York
  • … and 6 more centers

Identifiers

NCT: NCT06241456 · FT825-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗