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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Fate Therapeutics
Study ID
NCT06241456
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 5, 2024
Status verified
Dec 2024
Primary completion
May 1, 2029
Completion
May 1, 2044

Study Design

Enrollment
351 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).
  • 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).

Primary Outcome Measure

Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to approximately 29 days ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
University of California San Diego Moores Cancer CenterLa JollaCalifornia92037-
Yale New Haven Hospital - Yale Cancer CenterNew HavenConnecticut06510-
University of Chicago Medical CenterChicagoIllinois60637-
Karmanos Cancer InstituteDetroitMichigan48201-
University of Minnesota Medical SchoolMinneapolisMinnesota55455-
Washington University School of MedicineSt LouisMissouri63110-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Oncology Hematology Care Clinial TrialsCincinnatiOhio45242-
Ohio State University - Comprehensive Cancer CenterColumbusOhio43210-
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104-
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
Sarah Cannon Research Institute (SCRI) - Oncology PartnersNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZUniversity of California San Diego Moores Cancer Center· La Jolla, CAYale New Haven Hospital - Yale Cancer Center· New Haven, CTUniversity of Chicago Medical Center· Chicago, ILKarmanos Cancer Institute· Detroit, MIUniversity of Minnesota Medical School· Minneapolis, MN

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