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

PHASE1RecruitingINTERVENTIONAL
Enrollment

351

Participants

Timeline

Start Date

January 5, 2024

Primary Completion Date

May 1, 2029

Study Completion Date

May 1, 2044

Conditions
Advanced Solid Tumor
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.

Trial Locations (15)

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

19107

RECRUITING

Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia

37203

RECRUITING

Sarah Cannon Research Institute (SCRI) - Oncology Partners, Nashville

43210

RECRUITING

Ohio State University - Comprehensive Cancer Center, Columbus

45242

RECRUITING

Oncology Hematology Care Clinial Trials, Cincinnati

48201

RECRUITING

Karmanos Cancer Institute, Detroit

55455

RECRUITING

University of Minnesota Medical School, Minneapolis

60637

RECRUITING

University of Chicago Medical Center, Chicago

63110

RECRUITING

Washington University School of Medicine, St Louis

73104

RECRUITING

OU Health Stephenson Cancer Center, Oklahoma City

77030

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

85234

RECRUITING

Banner MD Anderson Cancer Center, Gilbert

92037

RECRUITING

University of California San Diego Moores Cancer Center, La Jolla

06510

RECRUITING

Yale New Haven Hospital - Yale Cancer Center, New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Fate Therapeutics

INDUSTRY

NCT06241456 - FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors | Biotech Hunter | Biotech Hunter