FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
Public ClinicalTrials.gov record NCT06241456. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06241456
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 351 participants
Conditions and interventions
Conditions
Interventions
- FT825 Drug
- Fludarabine Drug
- Cyclophosphamide Drug
- Bendamustine Drug
- Docetaxel Drug
- Cisplatin Drug
- Cetuximab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 4, 2024
- Primary completion
- Apr 30, 2029
- Completion
- Apr 30, 2044
- Last update posted
- Dec 8, 2025
2024 – 2044
United States locations
- U.S. sites
- 14
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | Recruiting |
| University of California San Diego Moores Cancer Center | La Jolla | California | 92037 | Recruiting |
| Yale New Haven Hospital - Yale Cancer Center | New Haven | Connecticut | 06510 | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | Recruiting |
| University of Minnesota Medical School | Minneapolis | Minnesota | 55455 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| Oncology Hematology Care Clinial Trials | Cincinnati | Ohio | 45242 | Recruiting |
| Ohio State University - Comprehensive Cancer Center | Columbus | Ohio | 43210 | Recruiting |
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Thomas Jefferson University, Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Sarah Cannon Research Institute (SCRI) - Oncology Partners | Nashville | Tennessee | 37203 | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06241456, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 8, 2025 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06241456 live on ClinicalTrials.gov.