Fate Therapeutics Presents Updated Phase 1 Clinical Data For FT819, Off-The-Shelf, Available On-Demand, Anti-CD19 CAR T-Cell Product Candidate, In Patients With SLE With Lupus Nephritis At ASN Kidney Week 2026

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

Clinical data reinforces the patient value of the ongoing RECLAIM-LN, a Phase 2 potentially registrational study of FT819 in refractory, moderate-to-severe SLE with LN

FT819 continues to offer a unique product profile with the simplicity to dose CAR T-cell therapy on-demand in the community setting

SAN DIEGO, Oct. 26, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative and broadly accessible pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced updated Phase 1 clinical data for FT819, its off-the-shelf, available on-demand, anti-CD19 CAR T-cell product candidate, in patients with systemic lupus erythematosus (SLE) with lupus nephritis (LN) were featured in an oral presentation at the American Society of Nephrology (ASN) Kidney Week 2026, held October 22–25 in Denver, Colorado.

The oral presentation, "Off-the-Shelf Anti-CD19 Chimeric Antigen Receptor (CAR)-T Cell Therapy with Less-Intensive Fludarabine-Free Conditioning in Lupus Nephritis: Phase 1 Safety and Efficacy," was presented on October 24, 2026, by Jonathan D. Graf, MD, Professor of Clinical Medicine, Division of Rheumatology at the University of California, San Francisco. The presentation reported data from the ongoing Phase 1 FT819-102 study as of the August 18, 2026, data cutoff.