A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
← catalyst calendarNCT06308978 · readout in 406 d
Sponsored by Fate Therapeutics (industry) · FATE — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
244estimated
Sites
21
Countries
France, Sweden, United Kingdom +1
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 | 2024-03-28 | actual | When the study began enrolling |
| Primary completion | 2027-09-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2042-09-30 | estimated | The whole study's end, after follow-up |
| First posted | 2024-03-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)
- Idiopathic Inflammatory Myositis (IIM)
- Systemic Sclerosis (SSc)
- Systemic Lupus Erythematosus (SLE)
- Lupus Nephritis
Interventions
- Drug: FT819
- Drug: Fludarabine — also filed as FLUDARA
- Drug: Cyclophosphamide — also filed as CYTOXAN
- Drug: Bendamustine
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with treatment-emergent adverse events (TEAEs)
measured Up to approximately 2 years
Number of participants with serious TEAEs
measured Up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
measured Up to approximately 29 days
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