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

Purpose

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.

Condition

  • Advanced Solid Tumor

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Regimen A: FT825 		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
    FT825 will be administered as an intravenous (IV) infusion at planned dose levels.
    Other names:
    • ONO-8250
  • Drug: Fludarabine
    Fludarabine will be administered as an IV infusion at planned dose levels.
    Other names:
    • FLUDARA
  • 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.
Experimental
Regimen B: FT825 + Cetuximab 		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
    FT825 will be administered as an intravenous (IV) infusion at planned dose levels.
    Other names:
    • ONO-8250
  • Drug: Fludarabine
    Fludarabine will be administered as an IV infusion at planned dose levels.
    Other names:
    • FLUDARA
  • 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.

Recruiting Locations

Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752 85234

University of California San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92037

Yale New Haven Hospital - Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06510

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637

Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201

University of Minnesota Medical School
Minneapolis 5037649, Minnesota 5037779 55455

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065

Oncology Hematology Care Clinial Trials
Cincinnati 4508722, Ohio 5165418 45242

Ohio State University - Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210

OU Health Stephenson Cancer Center
Oklahoma City 4544349, Oklahoma 4544379 73104

Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19107

Sarah Cannon Research Institute (SCRI) - Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

More Details

NCT ID
NCT06241456
Status
Recruiting
Sponsor
Fate Therapeutics

Study Contact

Fate Trial Disclosure
858-875-1800
FateTrialDisclosure@fatetherapeutics.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center