On December 8, 2025 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 off-the-shelf cellular immunotherapies to patients for broad accessibility, reported updated clinical data from its ongoing Phase 1 trial evaluating its FT819 off-the-shelf iPSC-derived CAR T-cell program in systemic lupus erythematosus (SLE) and unveiled new preclinical data from next-generation off-the-shelf iPSC-derived CAR T-cell programs for hematologic malignancies and autoimmune diseases at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, Florida.

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"We are very pleased with the accelerating patient enrollment, the expansion of U.S. clinical sites, and the addition of international clinical sites, which together are enabling broader access to FT819 for patients suffering with lupus," said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. "The updated FT819 clinical data continue to demonstrate meaningful and durable responses with the use of less-intensive conditioning chemotherapy and a differentiated safety profile, reinforcing our goal to commence a registrational study for FT819 in 2026 and highlighting the potential of FT819 as an ideal CAR T-cell therapy for various autoimmune diseases. At the same time, our next-generation programs, FT836 and FT839, are showing substantial progress, with enhanced potency, functional persistence, and multifunctional engineering that are designed to extend the benefits of our platform across hematologic malignancies and solid tumors. These advances highlight the continued momentum of our iPSC-derived off-the-shelf CAR T-cell pipeline and our commitment to delivering scalable, on-demand and broadly accessible CAR T-cell therapies worldwide."

The clinical update includes data from the Company’s ongoing Phase 1 basket trial of FT819, its lead product candidate, across 13 enrolled patients; 12 with SLE (10 of whom have at least one month of post-treatment follow-up) and one with systemic sclerosis. The updated results demonstrate sustained clinical responses, durable B-cell depletion in a potential dose-response manner, and a differentiated safety profile without the need for intensive-conditioning chemotherapy that typically consists of multiple days of combined doses of cyclophosphamide and fludarabine. With the strength of this clinical data, the Company continues to advance preparations for a pivotal study and is engaged in discussions with the United States Food and Drug Administration (FDA) under its Regenerative Medicine Advanced Therapy (RMAT) designation regarding plans to initiate registrational trial of FT819 in 2026.

At ASH (Free ASH Whitepaper), the Company also presented new preclinical data for two next-generation iPSC-derived CAR T-cell programs designed for use in both oncology and autoimmunity. These programs demonstrate substantial improvements in functional activity and persistence, drug product consistency and uniformity, and breadth of antigen-targeting mechanisms compared with existing autologous and in vivo CAR T-cell platforms.

FT819-102 Clinical Trial Update

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master iPSC line serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to potentially reach a broad patient population.

As of a November 25, 2025 data cut off date, 12 SLE patients were treated by 5 enrolling clinical sites, with 14 clinical sites in total (11 in United States and 3 in United Kingdom) now activated. Baseline characteristics were consistent with a high disease burden patient population:

median SLE duration was 8.7 years, median 7 prior therapies;
median 14 Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (baseline range 8-20);
mean 2.3±0.4 Physician Global Assessment (PGA); and
mean 23±13 Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-Fatigue) score.
As of an October 22, 2025 data cut off date, 10 SLE patients had ≥ 1 month follow up, with 6 of the 10 patients having active lupus nephritis. Preliminary data in Regimen A (with patients receiving a single FT819 dose after pretreatment with either a single dose of cyclophosphamide or two doses of bendamustine) show mean SLEDAI-2K score across both dose levels (DL1, 360 million cells; DL2, 900 million cells) decreased progressively from baseline:

DL1 SLEDAI-2K score decreased from a mean of 15.2 (n=5) at baseline to a mean of 10 at month 3 (n=2), and to a mean of 6 at month 6 (n=2), representing mean percent drops of 50% and 70%, respectively; and
DL2 SLEDAI-2K score decreased from a mean of 14.3 (n=3) at baseline to a mean of 6 at month 3 (n=2) and to 4 at month 6 (n=1), representing mean percent drops of 65% and 78%, respectively.
Clinical SLEDAI-2K (excluding anti-dsDNA and complement) of 0 was achieved in 5 out of 10 patients, two of whom had resumed an immunosuppressive agent that had previously failed to achieve a clinical SLEDAI-2K of 0 prior to FT819. Two lupus nephritis patients had greater than 3-month follow up, with both achieving complete renal response (CRR) at 2 months and 6 months, respectively. FACIT-fatigue scores improved meaningfully for all patients who had more than one assessment. B-cell depletion was observed, with reconstitution towards predominately naïve cells within the first 3 months. There were no observed dose limiting toxicities; no Grade >2 CRS, ICANS, or GVHD were reported. All patients were treated with FT819 that was available on-demand.

Below are links to the Company Presentations at the 2025 ASH (Free ASH Whitepaper) Annual Meeting & Exposition:

Saturday December 6, 2025

Targeting of tumor antigen CD38 and stress antigens MICA/B by CAR T cells provides a unique approach for the comprehensive treatment of multiple myeloma
Poster Presentation Number: 2350

Session Title: CAR-T Cell Therapies: Basic and Translational: Poster I

Session Time: 5:30 PM – 7:30 PM ET

Sunday December 7, 2025

Development of next generation multi-antigen targeting off-the-shelf CAR T cells for conditioning-free treatment of B-cell lymphoma
Poster Presentation Number: 4121

Session Title: CAR-T Cell Therapies: Basic and Translational: Poster II

Session Time: 6:00 PM – 8:00 PM ET

Monday December 8, 2025

The development of an off-the-shelf CAR T-cell therapy targeting CD19 and CD38 for broad application in autoimmune disease
Poster Presentation Number: 5895

Session Title: CAR-T Cell Therapies: Basic and Translational: Poster III

Session Time: 6:00 PM – 8:00 PM ET

(Press release, Fate Therapeutics, DEC 8, 2025, View Source [SID1234661256])