FT819 - (RECLAIM-LN)

October 26, 2026: Fate Therapeutics (NASDAQ: FATE) reported updated Phase 1 FT819-102 data for FT819, an off-the-shelf anti-CD19 CAR-T, in systemic lupus erythematosus with lupus nephritis (LN), presented October 24 at ASN Kidney Week 2026. In autoimmune patients treated with a single FT819 dose plus less-intensive, fludarabine-free conditioning (N=29), no dose-limiting toxicities, ICANS, GvHD, IEC-HS, or deaths were reported; no CRS above Grade 2 occurred. Grade 1–2 CRS occurred in 17.2%, Grade ≥3 infections in 6.9% (both UTIs), and Grade ≥3 cytopenias in 20.7%.

In active LN patients treated with FT819 plus bendamustine—the regimen chosen for the ongoing Phase 2 RECLAIM-LN study—all Month 6-evaluable patients (n=2) achieved either complete renal response or primary efficacy renal response, with about 50% mean reduction in proteinuria; one CRR was sustained through Month 24. In the broader Regimen A LN cohort, 50% of Month 6-evaluable patients (n=6) achieved CRR or PERR.

The company also reported declines in clinical SLEDAI-2K, about 75% reduction in Physician Global Assessment by Month 6, and 2-fold improvement in FACIT-Fatigue. These data support the ongoing potentially registrational Phase 2 RECLAIM-LN trial (FT819-201; NCT07570862) in refractory, moderate-to-severe SLE with LN.