Fate Therapeutics Presents Updated Preliminary Data for FT819 in Active Lupus Nephritis at American Society of Nephrology Kidney Week 2026
Key Highlights
- ➤FT819 plus bendamustine delivered 100% renal response at Month 6 in active lupus nephritis
- ➤Mean urine protein-to-creatinine ratio declined approximately 50% at Month 6
- ➤FT819 caused no dose-limiting toxicities, ICANS, GvHD, IEC-HS, or deaths across 29 patients
- ➤Grade 1–2 cytokine release syndrome occurred in 5 patients, while Grade ≥3 infections affected 2
- ➤Fate Therapeutics advances FT819 into Phase 2 potentially registrational RECLAIM-LN study
Expert Statements
Jonathan D. Graf, Professor of Clinical Medicine, Division of Rheumatology, University of California, San Francisco
“While these results are early, the initial efficacy and, even more importantly, the safety seen with FT819 is extremely promising”
Jonathan D. Graf, Professor of Clinical Medicine, Division of Rheumatology, University of California, San Francisco
“In this Phase 1 study, patients receiving even the lowest doses of FT819 are achieving significant clinical responses while showing no signs of serious toxicity.”
Jonathan D. Graf, Professor of Clinical Medicine, Division of Rheumatology, University of California, San Francisco
“I am extremely excited to see the full results from this study once it is completed and look forward to the Phase 2 trial in LN.”
Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics
“While preliminary, the Phase 1 lupus nephritis clinical efficacy data, concurrent with the discontinuation of standard of care medication such as immunosuppressants, combined with favorable safety data across all patients treated with a single dose of FT819 and less-intensive conditioning, continues to be very encouraging and builds further confidence and momentum in our ongoing RECLAIM-LN study, a Phase 2 potentially registrational trial”
Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics
“The observed renal responses and favorable safety profile are also complemented with meaningful decreases in lupus disease activity scores and importantly, significant improvement in fatigue scores, a quality-of-life improvement aspect often not achieved with currently approved therapies in lupus nephritis.”
Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics
“To be able to deliver such results in an outpatient setting with the on-demand availability of FT819 for broadened patient access is a game changer for patients with this challenging disease who currently lack good treatment options.”
Active LN patients in the Phase 1 study treated with FT819 and the less-intensive conditioning (bendamustine) regimen selected for the RECLAIM-LN study achieved 100% renal response at Month 6, with approximately 50% mean reduction in proteinuria
Encouraging safety profile with no dose-limiting toxicities, high-grade CRS, ICANS, GvHD or IEC-HS in autoimmune patients treated with a single dose of FT819; low incidences of infection and cytopenia were also observed
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