Fate Therapeutics Presents Updated Preliminary Data for FT819 in Active Lupus Nephritis at American Society of Nephrology Kidney Week 2026

Active LN patients in the Phase 1 study treated with FT819 and the less-intensive conditioning (bendamustine) regimen selected for the RECLAIM-LN study achieved 100% renal response at Month 6, with approximately 50% mean reduction in proteinuria

Encouraging safety profile with no dose-limiting toxicities, high-grade CRS, ICANS, GvHD or IEC-HS in autoimmune patients treated with a single dose of FT819; low incidences of infection and cytopenia were also observed

Clinical data reinforces the patient value of the ongoing RECLAIM-LN, a Phase 2 potentially registrational study of FT819 in refractory, moderate-to-severe SLE with LN

FT819 continues to offer a unique product profile with the simplicity to dose CAR T-cell therapy on-demand in the community setting

SAN DIEGO, Oct. 26, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative and broadly accessible pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced updated Phase 1 clinical data for FT819, its off-the-shelf, available on-demand, anti-CD19 CAR T-cell product candidate, in patients with systemic lupus erythematosus (SLE) with lupus nephritis (LN) were featured in an oral presentation at the American Society of Nephrology (ASN) Kidney Week 2026, held October 22–25 in Denver, Colorado.

The oral presentation, "Off-the-Shelf Anti-CD19 Chimeric Antigen Receptor (CAR)-T Cell Therapy with Less-Intensive Fludarabine-Free Conditioning in Lupus Nephritis: Phase 1 Safety and Efficacy," was presented on October 24, 2026, by Jonathan D. Graf, MD, Professor of Clinical Medicine, Division of Rheumatology at the University of California, San Francisco. The presentation reported data from the ongoing Phase 1 FT819-102 study as of the August 18, 2026, data cutoff.

“While these results are early, the initial efficacy and, even more importantly, the safety seen with FT819 is extremely promising,” said Dr. Graf. “In this Phase 1 study, patients receiving even the lowest doses of FT819 are achieving significant clinical responses while showing no signs of serious toxicity. I am extremely excited to see the full results from this study once it is completed and look forward to the Phase 2 trial in LN.”

Across all 29 autoimmune patients, including those with SLE, treated with a single dose of FT819 following less-intensive, fludarabine-free conditioning, FT819 was well tolerated, supporting outpatient administration and expanded patient access. In a cohort of patients with active LN treated with FT819 and bendamustine conditioning, while discontinuing immunosuppressant medications - the regimen selected for the ongoing Phase 2 RECLAIM-LN study - all patients evaluable at Month 6 either achieved a complete renal response (CRR) or primary efficacy renal response (PERR). These outcomes were accompanied by meaningful improvements in lupus disease activity, significant reductions in fatigue, and strong evidence of B-cell reset and remodeling.

“While preliminary, the Phase 1 lupus nephritis clinical efficacy data, concurrent with the discontinuation of standard of care medication such as immunosuppressants, combined with favorable safety data across all patients treated with a single dose of FT819 and less-intensive conditioning, continues to be very encouraging and builds further confidence and momentum in our ongoing RECLAIM-LN study, a Phase 2 potentially registrational trial,” said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. “The observed renal responses and favorable safety profile are also complemented with meaningful decreases in lupus disease activity scores and importantly, significant improvement in fatigue scores, a quality-of-life improvement aspect often not achieved with currently approved therapies in lupus nephritis. To be able to deliver such results in an outpatient setting with the on-demand availability of FT819 for broadened patient access is a game changer for patients with this challenging disease who currently lack good treatment options.”

Key findings from the presentation include:

Safety profile – all patients treated (N=29) with a single dose of FT819 with less-intensive conditioning:

• Favorable safety and tolerability supportive of outpatient delivery. All patients tolerated FT819 with less-intensive conditioning without a dose-limiting toxicity. No immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD), immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), or deaths were reported, and no cytokine release syndrome (CRS) above Grade 2 was observed. Low-grade (Grade 1–2) CRS occurred in 5 patients (17.2%). Grade ≥3 infections occurred in 2 patients (6.9%), both urinary tract infections, and Grade ≥3 cytopenias occurred in 6 patients (20.7%). In the U.S., FT819 is being administered in the outpatient setting.
  

Summary of efficacy and translational data from Phase 1 FT819-102 study as of a data cut-off date of August 18, 2026:  

• Selected Phase 2 conditioning regimen shows 100% renal response of CRR or PERR and approximately 50% mean reduction in proteinuria at Month 6 in active LN. Patients who were treated with FT819 plus bendamustine and discontinued standard of care therapy per study protocol (hydroxychloroquine and low-dose prednisone permitted) and who had follow up to Month 6 (n=2) achieved a complete renal response (CRR) or primary efficacy renal response (PERR), and mean urine protein-to-creatinine ratio (UPCr), a key measure of kidney damage in LN, decreased by approximately 50% from baseline. The renal response of CRR was sustained through Month 24 in the single patient to reach this timepoint as of the data cutoff date.
• LN patients in Regimen A show 50% renal response at Month 6. In the broader conditioning cohort, Regimen A (administration of FT819 with less-intensive conditioning consisting of either cyclophosphamide or bendamustine), 50% of Class III or Class IV with or without concomitant Class V LN patients with follow up to Month 6 (n=6) achieved CRR and PERR, respectively. Per study protocol, patients discontinued immunosuppressant medications (hydroxychloroquine and low-dose prednisone permitted) prior to treatment with FT819.
• Clinically meaningful improvements in disease activity and fatigue. Clinical SLEDAI-2K scores declined as early as Month 1 in both patients with active LN and the overall SLE population (n=11), with reductions maintained in patients with longer follow-up. Physician Global Assessment (PGA), a clinician-rated measure of overall lupus disease activity, fell by approximately 75% from baseline by Month 6. Patient-reported fatigue, measured by FACIT-Fatigue, improved 2-fold from baseline by Month 6, with mean scores moving out of the range associated with moderate-to-severe fatigue.
• Deep B-cell depletion followed by reconstitution of naïve B cells. FT819 drove durable B-cell depletion (n=11), and concurrently targeted B cells in secondary lymphoid tissue (n=3), indicating activity beyond peripheral blood. During the subsequent B-cell reconstitution, the emerging population reached normal levels for many patients and shifted toward a less-differentiated state at Month 6, with a higher proportion of naïve B cells and a lower proportion of class-switched memory B cells (n=5).
• Elimination of the top B-cell clones. The 50 most abundant B-cell receptor clones present at baseline were seen to be absent by Month 1 post FT819 treatment and did not re-emerge through Month 6. The elimination of these baseline dominant clones, which may include proliferating disease-driving autoreactive B cells, combined with the reconstitution of a naïve B-cell population, reinforces the remodeling of the B-cell compartment and is suggestive of an immune reset post FT819 treatment.
• Expanded patient reach and accessibility. FT819 is manufactured from a clonal master cell bank, produced at low cost of goods and is available on demand, with no need to collect and manufacture patient's own cells, further eliminating patient burden and risk. Combined with less-intensive conditioning that avoids fludarabine, which is cleared by the kidneys and requires dose adjustment in patients with impaired renal function, treatment with FT819 could broaden access to CAR T-cell therapy for patients with LN.

These data support the advancement of FT819 into the ongoing Phase 2 RECLAIM-LN study (FT819-201; NCT07570862) in patients with refractory, moderate-to-severe SLE with lupus nephritis, which uses the same bendamustine conditioning regimen.

About FT819

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product candidate engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank 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 enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant numbers: CLIN2-16303 and CLIN2-20291)

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.

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Contact:

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