Fate Therapeutics presents 6-month data on first lupus patient

Fate Therapeutics (FATE) presented initial clinical and translational data from the first patient treated in its FT819 Phase 1 Autoimmunity study for moderate-to-severe systemic lupus erythematosus – SLE – at the American College of Rheumatology Convergence in Washington, D.C. The patient, a 27-year-old African American-Asian woman diagnosed with lupus nephritis, or LN, over ten years ago, received fludarabine-free conditioning followed by a single dose of FT819. The patient achieved clinical remission and low lupus disease activity state as of Month 6 follow-up. The patient continues on-study, in clinical remission, and free of all immunosuppressive therapies as of a data cutoff date of November 11. FT819 is the company’s off-the-shelf product candidate. As of the data cutoff date, the patient has experienced no Grade greater than or equal to3 AEs, no serious adverse events, and no events of any grade of cytokine release syndrome, immune effector-cell associated neurotoxicity syndrome or graft-versus-host disease. The patient reported that her debilitating fatigue had entirely resolved without further treatment. As of the data cutoff date, the patient continues in DORIS clinical remission and remains free of all immunosuppressive therapy. The company plans to present clinical and translational data from the first three patients at the American Society of Hematology Annual Meeting being held in San Diego, CA on December 7-10.