Fate Therapeutics(US:FATE) Globenewswireยท2025-10-26 15:30Core Insights - Fate Therapeutics has reported promising initial clinical data for FT819, an off-the-shelf CAR T-cell therapy for moderate-to-severe systemic lupus erythematosus (SLE), showing significant clinical activity and a favorable safety profile [2][3] - The company aims to accelerate patient enrollment in its Phase 1 trial and is in discussions with the FDA for a registrational study design, targeting a pivotal study initiation in 2026 [2][10] Clinical Data Summary - A total of 10 patients with treatment-refractory moderate-to-severe SLE have been treated with FT819, with 5 patients surpassing the 3-month post-treatment evaluation showing significant reductions in SLE Disease Activity Index (SLEDAI-2K) scores [1][3] - Patients with lupus nephritis achieved complete renal response (CRR) at 6 months, with one patient maintaining drug-free remission at 15 months [1][4] Treatment Regimens - The study includes two regimens: a less-intensive conditioning regimen and a conditioning-free regimen, with patients showing meaningful improvements in disease activity scores and renal function [3][6] - In the less-intensive conditioning regimen, patients demonstrated significant reductions in SLEDAI-2K scores, with one patient achieving a 16-point reduction and maintaining remission [4][5] Safety Profile - FT819 has shown a favorable safety profile, with no dose-limiting toxicities reported and low incidence of cytokine release syndrome (CRS) among treated patients [9] - All patients were discharged on the same day post-infusion, indicating potential for outpatient administration [9] Program Expansion and Future Outlook - The company is expanding its clinical program to include additional cohorts for other autoimmune diseases, with over 60 patients treated across various indications [9] - Fate Therapeutics has approximately 600 cryopreserved drug product bags of FT819 available for patient treatment [10]