Fate Therapeutics Presents Updated Preliminary Data for FT819 in Active Lupus Nephritis at American Society of Nephrology Kidney Week 2026
Fate Therapeutics presented updated Phase 1 data for FT819, its off-the-shelf anti-CD19 CAR T-cell therapy, in active lupus nephritis at ASN Kidney Week 2026. In the bendamustine-conditioning regimen selected for the Phase 2 RECLAIM-LN study, all evaluable active LN patients (n=2) achieved a complete renal response or primary efficacy renal response at Month 6, with roughly 50% mean reduction in proteinuria, and one patient sustained CRR through Month 24. Across all 29 autoimmune patients treated, FT819 with less-intensive, fludarabine-free conditioning showed no dose-limiting toxicities, no high-grade CRS, ICANS, GvHD or IEC-HS, supporting outpatient administration.
Key figures
- Drug Name
- FT819
- Phase Of Trial
- Phase 1
- Data cutoff
- August 18, 2026
- Grade 1 2 crs
- 17.2% (5/29)
- Patients treated
- 29
- Pga reduction month6
- approximately 75%
- Proteinuria reduction
- approximately 50% mean reduction at Month 6
- Grade 3plus cytopenias
- 20.7% (6/29)
- Grade 3plus infections
- 6.9% (2/29)
- Regimen A renal response month6
- 50% (n=6)
- Renal response month6 selected regimen
- 100% of evaluable patients (n=2) achieved CRR or PERR
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