Fate Therapeutics Announces Encore Clinical Data Presentation of FT819 Off-the-Shelf CAR T-Cell Product Candidate at the CCR – West 2026 Meeting

SAN DIEGO, Sept. 09, 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 to patients with cancer and autoimmune diseases, today announced clinical data from its off-the-shelf anti-CD19 CAR T-cell product candidate FT819, and pre-clinical data from its off-the-shelf anti-CD19 and CD38 CAR T-cell product candidate FT839 will be featured at the Congress of Clinical Rheumatology West (CCR – West) meeting, being held in Huntington Beach, CA on September 17-20, 2026.

The Company is presenting encore clinical data from the systemic lupus erythematosus (SLE) study arm of its ongoing Phase 1 trial in support of its advancing RECLAIM-LN trial, a Phase 2 potentially registrational trial in lupus nephritis (LN). The presentation includes clinical safety, efficacy and translational data from 16 SLE patients treated in Regimen A of the Phase 1 trial, which is evaluating a single dose of FT819 combined with less-intensive, fludarabine-free conditioning chemotherapy, of whom 13 patients have completed at least one month of follow-up as of May 14, 2026 data cutoff.

Highlights of the FT819 presentation include:

• Favorable Tolerability: Among SLE patients treated in Regimen A, there were no dose-limiting toxicities, no cytokine release syndrome of Grade 3 or greater, and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD), or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). In addition, low and manageable rates of infection and cytopenia were observed.
• Designed for Safety: In addition to the use of less-intensive conditioning, which is intended to reduce the frequency of adverse events associated with lymphodepletion, FT819 incorporates multiple design attributes intended to support a favorable safety profile, including the combination of a novel tuned CAR motif and targeted insertion into the TRAC locus designed to prevent uncontrolled T-cell expansion, and precise engineering at the clonal level with a well-vetted master cell bank serving as the consistent starting point for routine manufacture to ensure drug product uniformity and reliability. Combined, these attributes incorporated at the molecular-, manufacture- and clinical-level are designed to provide a unique, planned advantage, with the goal of treating patients with CAR T cells in an effective yet safe manner.
• Early and Maintained Efficacy: As of the cutoff date, clinically meaningful improvements were observed in lupus disease activity and patient-reported outcome measures, including Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue scores, in patients treated in the Phase 1 trial. Improvements were observed early following treatment with FT819 using less-intensive conditioning therapy in Regimen A (≥1-month follow-up) and were maintained over time.
• Phase 1 Data Applicable to RECLAIM-LN: Month 6 UPCr levels in patients with active LN at baseline decreased by 1.15 g/g in all patients treated in Regimen A and, specifically, decreased by 1.8 g/g in patients treated with a single dose of FT819 and bendamustine, representing a meaningful therapeutic mark in the management of kidney disease. 

FT819 Presentation

Title: Safety and Efficacy of an Off-the-Shelf Anti-CD19 CAR T-Cell Therapy with Reduced Conditioning in SLE Supporting Same-Day Discharge

Presentation Date / Time: Friday, September 18, 2026, at 3:40 p.m. PT

FT839 Presentation

Title: Off-the-Shelf Dual-CAR T-Cell Therapy: Targeting B and T Cells in Autoimmune Disease Without Preconditioning

Presentation Date / Time: Friday, September 18, 2026, at 3:40 p.m. PT

Presentation materials will be available following the event on the Fate website located here: Fate Publications & Presentations

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com

Forward-Looking Statements

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Contact:

Ryan Douglas
Fate Therapeutics, Inc.
IR@fatetherapeutics.com