Fate Therapeutics, Inc. (NASDAQ: FATE) announced it will present preliminary clinical data from its off-the-shelf CAR T-cell product candidate, FT819, at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting in Montréal, Canada, on July 9, 2026.

The presentation will cover data from the systemic sclerosis (SSc) arm of the company's ongoing Phase 1 basket trial, which evaluates FT819 across various autoimmune diseases. The trial enrolls treatment-refractory patients who have experienced prior treatment failure and have ongoing active disease. Eligibility was expanded to include patients with up to 15 years of disease duration.

Data from the first four SSc patients treated as of a June 12, 2026 cutoff will be highlighted. Three patients received Regimen A, using less-intensive conditioning chemotherapy with cyclophosphamide or bendamustine alone, while one patient received Regimen B with no conditioning chemotherapy. All four patients demonstrated a Revised Composite Response Index in Systemic Sclerosis (rCRISS) score of 25 or higher, with improvement in Modified Rodnan Skin Score (mRSS) at three months post-treatment.

No cases of Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, Graft versus Host Disease, hypogammaglobulinemia, or deaths were reported among SSc participants in the study.

FT819 is also being evaluated in Systemic Lupus Erythematosus as part of the same basket trial. The company has indicated a Phase 2 potentially registrational trial is planned in Lupus Nephritis.

FT819 is manufactured from a clonal master induced pluripotent stem cell (iPSC) bank, which the company says allows for off-the-shelf availability. The research received funding from the California Institute for Regenerative Medicine (CIRM), grant number CLIN2-16303.