Fate Therapeutics to Present Preliminary Clinical Data of FT819 Off-the-Shelf CAR T-Cell Product Candidate for Systemic Sclerosis at the ISSCR 2026 Annual Meeting

About this update from Fate Therapeutics, Inc.

SAN DIEGO, July 06, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies broadly to patients with cancer and autoimmune disease, today announced that preliminary clinical data from the Company’s off-the-shelf CAR T-cell product candidate, FT819, will be presented at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting, being held at the Palais des congrès de Montréal in Montréal, Canada on July 8 - 11, 2026. The Company is participating in the Clinical Trials Update oral session and will present on the Systemic Sclerosis (SSc) arm of its ongoing Phase 1 basket trial evaluating FT819 in various autoimmune diseases. The cohort is enrolling a treatment-refractory patient population, with eligibility requiring both prior treatment failure and ongoing active disease. The upper limit on disease duration for study entry was broadened to include patients with up to 15 years of disease duration, an intentional design choice to increase inclusivity while evaluating the therapy across a broader spectrum of patients. Highlights of the presentation include data from the first four SSc patients treated as of the June 12, 2026 data cutoff. Three of the four patients were treated under Regimen A with less-intensive conditioning chemotherapy (cyclophosphamide or bendamustine alone) and one patient was treated under Regimen B with no conditioning chemotherapy. All participants demonstrated a Revised Composite Response Index in Systemic Sclerosis (rCRISS)25 or higher with meaningful mean improvement in the Modified Rodnan Skin Score (mRSS) at 3 months post treatment. The treatment was well tolerated with no Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Graft versus Host Disease (GvHD), hypogammaglobulinemia, or deaths reported in SSc participants on study. These data points reinforce the well-tolerated safety profile of FT819 and demonstrate encouraging clinical activity with the use of less-intensive or no conditioning chemotherapy, supporting its continued advancement as an off-the-shelf, on-demand, outpatient CAR T-cell therapy for SSc, an autoimmune disease with significant unmet need. FT819 is also being evaluated in Syste...

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