Fate Therapeutics Presents New Phase 1 Clinical Data of FT819 Off-the-shelf, CAR T-cell Product Candidate for Systemic Lupus Erythematosus

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Fate Therapeutics, Inc.
Fate Therapeutics, Inc.

All Three Patients Treated in First Dose Cohort Administered Fludarabine-free Conditioning and Show Rapid, Deep, and Sustained B-cell Depletion with Favorable Safety Profile

First Patient to Reach 6-Month Follow-up Remains in DORIS Clinical Remission and Free of All Immunosuppressive Therapies

Company Plans to Initiate Dose Expansion at First Dose Level of 360M Cells

SAN DIEGO, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today presented new clinical and translational data from the Company’s FT819 Phase 1 Autoimmunity study for moderate-to-severe systemic lupus erythematosus (SLE) at the American Society of Hematology (ASH) Annual Meeting being held in San Diego, CA. The first three study patients, each of whom presented with active lupus nephritis (LN) despite having been treated with multiple standard-of-care therapies, received fludarabine-free conditioning followed by a single dose of FT819 at 360 million cells. There were no dose-limiting toxicities (DLTs), no events of any grade of cytokine release syndrome (CRS), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD), and rapid, deep, and sustained elimination of CD19+ B cells in the periphery was observed during the first month of treatment. FT819 is the Company’s off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate comprised of CD8αβ+ T cells with a memory phenotype and high CXCR4 expression to promote tissue trafficking.

“We continue to be very pleased with early clinical observations of fludarabine-free conditioning and FT819 off-the-shelf, CAR T-cell therapy in patients with moderate-to-severe SLE. The remarkable experience of the first patient treated in April is ongoing, as the patient remains on-study in drug-free clinical remission. In addition, the initial clinical and translational data from the two additional patients treated at the first dose level continue to support the potential for disease transformation,” said Bob Valamehr, President of Research and Development of Fate Therapeutics. “We are now initiating dose expansion at this first dose level to accelerate development, and are also escalating dose based on the favorable safety profile observed. In addition, I am pleased to announce that the first patient has now been treated with FT819 as an add-on to maintenance therapy without conditioning chemotherapy. We believe our therapeutic approach is highly-differentiated and has the potential to transform disease outcomes without requiring patient apheresis, discontinuation of maintenance therapy, intense conditioning chemotherapy, and extended hospitalization.”