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

NCT06241456 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: FT825-101
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Number of participants with dose limiting toxicities (DLTs)

  The number of participants with DLTs will be reported.

  Up to approximately 29 days

• Number of participants with treatment-emergent adverse events (TEAEs)

  The number of participants with TEAEs will be reported.

  Up to approximately 2 years

• Severity of AEs

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

  Up to approximately 2 years

Secondary Outcomes (5)

• Investigator-Assessed Overall Response Rate (ORR)

  Up to approximately 2 years

• Investigator-Assessed Duration of Response (DOR)

  Up to approximately 2 years

• Progression-Free Survival (PFS)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 2 years

• Plasma Concentration of FT825

  At designated time points up to approximately 56 days

Study Arms (2)

Regimen A: FT825

EXPERIMENTAL

Participants with advanced HER2-expressing solid tumors receive FT825 following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment).

Drug: FT825; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Bendamustine; Drug: Docetaxel; Drug: Cisplatin

Regimen B: FT825 + Cetuximab

EXPERIMENTAL

Participants with advanced epidermal growth factor receptor (EGFR)-expressing solid tumors receive FT825 in combination with cetuximab following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment).

Drug: FT825; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Bendamustine; Drug: Docetaxel; Drug: Cisplatin; Drug: Cetuximab

Interventions

FT825 DRUG

FT825 will be administered as an intravenous (IV) infusion at planned dose levels.

Also known as: ONO-8250

Regimen A: FT825; Regimen B: FT825 + Cetuximab

Fludarabine DRUG

Fludarabine will be administered as an IV infusion at planned dose levels.

Also known as: FLUDARA

Regimen A: FT825; Regimen B: FT825 + Cetuximab

Cyclophosphamide DRUG

Cyclophosphamide will be administered as an IV infusion at planned dose levels.

Regimen A: FT825; Regimen B: FT825 + Cetuximab

Bendamustine DRUG

Bendamustine will be administered as an IV infusion at planned dose levels.

Regimen A: FT825; Regimen B: FT825 + Cetuximab

Docetaxel DRUG

Docetaxel will be administered as an IV infusion at planned dose levels.

Regimen A: FT825; Regimen B: FT825 + Cetuximab

Cisplatin DRUG

Cisplatin will be administered as an IV infusion at planned dose levels.

Regimen A: FT825; Regimen B: FT825 + Cetuximab

Cetuximab DRUG

Cetuximab will be administered as an IV infusion at planned dose levels.

Regimen B: FT825 + Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fate Therapeutics: lead

Study Sites (14)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

University of California San Diego Moores Cancer Center

La Jolla, California, 92037, United States

RECRUITING

Yale New Haven Hospital - Yale Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

University of Minnesota Medical School

Minneapolis, Minnesota, 55455, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Oncology Hematology Care Clinial Trials

Cincinnati, Ohio, 45242, United States

RECRUITING

Ohio State University - Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Sarah Cannon Research Institute (SCRI) - Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

fludarabine; fludarabine phosphate; Cyclophosphamide; Bendamustine Hydrochloride; Docetaxel; Cisplatin; Cetuximab

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Director

  Fate Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Fate Trial Disclosure

CONTACT

858-875-1800; FateTrialDisclosure@fatetherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 5, 2024
• Study Start: January 5, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2044
• Last Updated: December 9, 2025

Record last verified: 2024-12

Locations

US (14)