FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
← catalyst calendarNCT06241456 · readout in 986 d
Sponsored by Fate Therapeutics (industry) · FATE — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
351estimated
Sites
14
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-01-05 | actual | When the study began enrolling |
| Primary completion | 2029-05-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2044-05-01 | estimated | The whole study's end, after follow-up |
| First posted | 2024-02-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Solid Tumor
Interventions
- Drug: FT825 — also filed as ONO-8250
- Drug: Fludarabine — also filed as FLUDARA
- Drug: Cyclophosphamide
- Drug: Bendamustine
- Drug: Docetaxel
- Drug: Cisplatin
- Drug: Cetuximab
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with dose limiting toxicities (DLTs)
measured Up to approximately 29 days
Number of participants with treatment-emergent adverse events (TEAEs)
measured Up to approximately 2 years
Severity of AEs
measured Up to approximately 2 years
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