Fate Therapeutics, Inc. (NASDAQ: FATE) announced it will present clinical data from its off-the-shelf anti-CD19 CAR T-cell product candidate FT819 at the Congress of Clinical Rheumatology West meeting in Huntington Beach, California, scheduled for September 17-20, 2026.

The presentation, set for September 18, 2026, covers encore clinical data from the systemic lupus erythematosus arm of an ongoing Phase 1 trial. The data includes safety, efficacy, and translational results from 16 SLE patients treated in Regimen A, which evaluates a single dose of FT819 combined with fludarabine-free conditioning chemotherapy. Of those 16 patients, 13 completed at least one month of follow-up as of a May 14, 2026 data cutoff.

According to the company's press release, no dose-limiting toxicities, no cytokine release syndrome of Grade 3 or greater, and no cases of immune effector cell-associated neurotoxicity syndrome, graft-versus-host disease, or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome were observed among patients treated in Regimen A. Low and manageable rates of infection and cytopenia were reported.

Clinical data showed improvements in lupus disease activity and patient-reported outcome measures, including Systemic Lupus Erythematosus Disease Activity Index and FACIT-fatigue scores. Month 6 urine protein-to-creatinine ratio levels in patients with active lupus nephritis at baseline decreased by 1.15 g/g across all Regimen A patients, and by 1.8 g/g in patients treated with a single dose of FT819 and bendamustine.

Fate Therapeutics is presenting the Phase 1 data in connection with its advancing RECLAIM-LN trial, a Phase 2 potentially registrational trial in lupus nephritis.

Pre-clinical data from FT839, the company's off-the-shelf anti-CD19 and CD38 CAR T-cell product candidate, will also be presented at the same event on September 18, 2026.