Fate Therapeutics Inc（FATE）資訊與事件FATEFate Therapeutics Inc

Fate Therapeutics Updates Phase 1 Clinical Data for FT819

Fate Therapeutics 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, or SLE, with lupus nephritis, or LN, were featured in an oral presentation at the American Society of Nephrology, or ASN, Kidney Week 2026, held October 22-25 in Denver, Colorado. The presentation reported data from the ongoing Phase 1 FT819-102 study as of the August 18, data cutoff. 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, or CRR, or primary efficacy renal response, or 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. All patients tolerated FT819 with less-intensive conditioning without a dose-limiting toxicity. No immune effector cell-associated neurotoxicity syndrome, or ICANS, graft-versus-host disease, or GvHD, immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome, or IEC-HS, or deaths were reported, and no cytokine release syndrome, or CRS, above Grade 2 was observed. Low-grade CRS occurred in 5 patients. Grade greater than or equal to3 infections occurred in 2 patients, both urinary tract infections, and Grade greater than or equal to3 cytopenias occurred in 6 patients. In the U.S., FT819 is being administered in the outpatient setting. Patients who were treated with FT819 plus bendamustine and discontinued standard of care therapy per study protocol and who had follow up to Month 6 achieved a complete renal response or primary efficacy renal response, and mean urine protein-to-creatinine ratio, 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. In the broader conditioning cohort, Regimen A, 50% of Class III or Class IV with or without concomitant Class V LN patients with follow up to Month 6 achieved CRR and PERR, respectively. Per study protocol, patients discontinued immunosuppressant medications prior to treatment with FT819. Clinical SLEDAI-2K scores declined as early as Month 1 in both patients with active LN and the overall SLE population, with reductions maintained in patients with longer follow-up. Physician Global Assessment, 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. FT819 drove durable B-cell depletion, 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 naive B cells and a lower proportion of class-switched memory B cells. 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 naive B-cell population, reinforces the remodeling of the B-cell compartment and is suggestive of an immune reset post FT819 treatment. 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 in patients with refractory, moderate-to-severe SLE with lupus nephritis, which uses the same bendamustine conditioning regimen.

Fate Therapeutics Awarded $15M Grant by CIRM

Fate Therapeutics announced that the California Institute for Regenerative Medicine, CIRM, has awarded the Company a $15M grant, through its CLIN2 program, to support the clinical development of RECLAIM-LN, the Company's Phase 2, potentially registrational trial of FT819 off-the-shelf CAR T cell in patients with refractory moderate-to-severe Systemic Lupus Erythematosus, SLE, with Lupus Nephritis. "We appreciate CIRM identifying the urgent need for new options in refractory lupus and are honored that they have recognized the potential of FT819 off-the-shelf CAR T-cell therapy to treat large number of these patients in need, including in underserved regions," said Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics. "This prestigious grant by CIRM supports the continued advancement of RECLAIM-LN, our Phase 2 potentially registrational trial, and our commitment to making CAR T-cell therapy broadly accessible to patients living with this serious disease."

Fate Therapeutics Presents Clinical Data for FT819

Fate Therapeutics 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 meeting, being held in Huntington Beach on September 17-20. The company is presenting encore clinical data from the systemic lupus erythematosus 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. 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. 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, graft-versus-host disease, or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome. In addition, low and manageable rates of infection and cytopenia were observed. 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. 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 and Functional Assessment of Chronic Illness Therapy-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 and were maintained over time. 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.