FT819 - (RECLAIM-LN)

September 9, 2026: Fate Therapeutics (NASDAQ: FATE) announced CCR West 2026 presentations for FT819 and FT839 in autoimmune disease. For FT819, encore clinical data from the SLE arm of an ongoing Phase 1 trial will be presented in support of RECLAIM-LN, a Phase 2 potentially registrational lupus nephritis trial. In Regimen A, 16 SLE patients received a single dose of FT819 with less-intensive, fludarabine-free conditioning; 13 had at least 1 month of follow-up as of the May 14, 2026 cutoff. Reported findings included no dose-limiting toxicities, no Grade 3+ cytokine release syndrome, and no ICANS, GvHD, or IEC-HS; infections and cytopenias were described as low and manageable. The company said clinically meaningful improvements were seen in SLEDAI and FACIT-fatigue scores, with early effects maintained over time. In patients with active lupus nephritis at baseline, month 6 UPCr decreased by 1.15 g/g across Regimen A and by 1.8 g/g in patients given FT819 plus bendamustine.

FT819 presentation: “Safety and Efficacy of an Off-the-Shelf Anti-CD19 CAR T-Cell Therapy with Reduced Conditioning in SLE Supporting Same-Day Discharge,” September 18, 2026 at 3:40 p.m. PT.

FT839 presentation: preclinical data on an off-the-shelf dual anti-CD19/CD38 CAR T-cell therapy targeting B and T cells without preconditioning, also on September 18, 2026 at 3:40 p.m. PT.