FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors (NCT06241456)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center — Gilbert, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- University of California San Diego Moores Cancer Center — La Jolla, California
- Yale New Haven Hospital - Yale Cancer Center — New Haven, Connecticut
- University of Chicago Medical Center — Chicago, Illinois
- Karmanos Cancer Institute — Detroit, Michigan
- University of Minnesota Medical School — Minneapolis, Minnesota
- Washington University School of Medicine — St Louis, Missouri
- Memorial Sloan Kettering Cancer Center — New York, New York
- Oncology Hematology Care Clinial Trials — Cincinnati, Ohio
- Ohio State University - Comprehensive Cancer Center — Columbus, Ohio
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma
- Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania
- Sarah Cannon Research Institute (SCRI) - Oncology Partners — Nashville, Tennessee
- The University of Texas MD Anderson Cancer Center — Houston, Texas
📞 Contact the Study Coordinator
Phone: (858) 875-1800
Email: FateTrialDisclosure@fatetherapeutics.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Solid Tumor
- Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression — Iowa City, Iowa
- A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors — Glendale, California
- QTX3046 in Patients With KRAS G12D Mutations — Grand Rapids, Michigan
- A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors — Houston, Texas
- First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer — Fullerton, California
- A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors — San Antonio, Texas
Explore by condition: All Advanced Solid Tumor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.