SAN DIEGO — September 9, 2026

Fate Therapeutics, Inc. announced that new clinical data for its off-the-shelf anti-CD19 CAR T-cell product candidate FT819 will be presented at the Congress of Clinical Rheumatology West (CCR – West) 2026 meeting in Huntington Beach, California, from September 17–20. The company will present encore clinical, safety and translational data from the systemic lupus erythematosus (SLE) arm of its ongoing Phase 1 trial, supporting the advancement of the RECLAIM-LN Phase 2 potentially registrational study in lupus nephritis. The presentation will include data from 16 SLE patients treated in Regimen A, which evaluates a single FT819 dose with less-intensive, fludarabine-free conditioning chemotherapy. The company said 13 patients had completed at least one month of follow-up at the May 14, 2026 data cutoff, providing additional clinical evidence as Fate progresses its iPSC-derived cellular immunotherapy platform.

FT819 Shows Favorable Safety With Reduced Conditioning

FT819 demonstrated a favorable tolerability profile in SLE patients treated under Regimen A, with no dose-limiting toxicities, Grade 3 or higher cytokine release syndrome, ICANS, graft-versus-host disease or IEC-HS reported. Fate also observed low and manageable rates of infection and cytopenia. The company is developing FT819 with multiple design and manufacturing features intended to support controlled and consistent CAR T-cell therapy. These include a tuned CAR motif and targeted TRAC-locus insertion, designed to limit uncontrolled T-cell expansion, alongside clonal engineering and a master cell bank intended to provide a consistent starting material for routine manufacturing. The use of less-intensive, fludarabine-free conditioning is also intended to reduce adverse events associated with traditional lymphodepletion. Together, these molecular, manufacturing and clinical design elements form a central component of Fate’s strategy to develop an off-the-shelf CAR T product capable of delivering cellular therapy with a more manageable treatment profile.

FT819 Generates Early and Maintained Clinical Activity

Clinical improvements were observed across measures of lupus disease activity and patient-reported outcomes following FT819 treatment, including changes in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and FACIT-Fatigue scores. Fate reported that these improvements appeared early following treatment with the less-intensive conditioning regimen and were maintained over time. The Phase 1 data also provide relevant information for the company’s lupus nephritis development strategy. Among patients with active lupus nephritis at baseline, Month 6 urine protein-to-creatinine ratio (UPCr) levels decreased by 1.15 g/g among all patients treated in Regimen A, while the reduction reached 1.8 g/g in patients receiving a single FT819 dose with bendamustine. Fate plans to use these clinical and translational findings to support the continued development of FT819 in autoimmune disease, including its planned RECLAIM-LN Phase 2 potentially registrational trial.

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Fate Expands iPSC-Derived Autoimmune Cell Therapy Pipeline

The FT819 program represents a major component of Fate Therapeutics’ strategy to apply its iPSC platform to off-the-shelf cellular immunotherapies for autoimmune diseases. In addition to FT819, the company will present preclinical data for FT839, an off-the-shelf dual-CAR T-cell candidate designed to target both B and T cells without preconditioning. Both programs reflect Fate’s broader focus on engineered iPSC-derived cellular products that can incorporate multiple therapeutic mechanisms and standardized manufacturing approaches. The upcoming CCR-West presentations provide an opportunity for the company to communicate clinical progress with FT819 while highlighting the potential of its next-generation cellular therapy pipeline. As Fate advances FT819 toward RECLAIM-LN and continues developing FT839, the company is positioning its iPSC-derived, off-the-shelf platform as a potential source of scalable cellular immunotherapies for patients with serious autoimmune diseases.

Source: Fate Therapeutics, ,press release