Updated safety data of 36 patients treated with FT819 across three regimens and four autoimmune disease indications with no dose-limiting toxicities continues to be favorable
100% (3 of 3) of extrarenal lupus patients treated with FT819 without the use of conditioning chemotherapy experienced measurable responses with two patients achieving the Definition of Remission in Systemic Lupus Erythematosus (DORIS) and the third achieving Lupus Low Disease Activity State (LLDAS)
First patient treated with two doses of FT819 achieved a significant reduction of Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) by 8 points at Month 1, achieving LLDAS by Month 2, which was sustained at Month 3
New preclinical data show FT839 eliminates a broad spectrum of activated immune cells in models of rheumatoid arthritis supporting immune cell reset in multicellular disease; COMPLETE™ Phase 1/2 basket trial open for enrollment
SAN DIEGO, Nov. 10, 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 disease, today announced that updated clinical data for FT819, together with translational and patient-perspective data, as well as preclinical data for FT839, are being presented in four presentations at the American College of Rheumatology (ACR) Convergence 2026, held November 6–11 in Orlando, Florida.
“Our recent clinical data presented at ACR continues to show that FT819 can be delivered in a safe and effective manner that fits into routine rheumatology care,” said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. “Across 36 patients, we have seen favorable tolerability with approximately one-third of patients having now received FT819 as outpatient therapy with many discharged on the same-day. We are also observing encouraging early clinical activity without the use of conditioning chemotherapy, which, when combined with a true off-the-shelf CAR T-cell manufacturing process, presents an opportunity to safely treat a larger population of patients. Achieving DORIS remission and LLDAS in patients without the use of conditioning chemotherapy also provides valuable clinical insight as we advance FT839, our dual-CAR T cell co-targeting CD19 and CD38 for broad elimination of activated immune cells, to treat complex autoimmune diseases such as rheumatoid arthritis without the reliance on conditioning chemotherapy. Moreover, early clinical evaluation of FT819 multi-dose regimen designed to deepen responses, is yielding encouraging outcomes. Our multi-dose regimens are made feasible by our distinct ability to manufacture CAR T-cells at scale, which reduces supply constraints and enables on-demand dosing at a low cost of goods. Lastly, we highlight that patients have consistently informed us that immediate access, shorter hospital stays and lighter conditioning matter most to them, and those are the precise attributes we have built into RECLAIM-LN, our Phase 2 potentially registrational trial in LN, as well as in our other CAR T-cell clinical programs.”
The presentations summarized below can be found here: FATE Presentations
Updated FT819 Phase 1 Clinical Data
The FT819 Phase 1 study is currently evaluating patients under one of three regimens: Regimen A, a single dose of FT819 following less-intensive fludarabine-free conditioning with cyclophosphamide or bendamustine; Regimen B, a single dose of FT819 without conditioning chemotherapy, added to stable background therapy; and Regimen C, two doses of FT819 on Day 1 and Day 15 following less-intensive fludarabine-free conditioning. As of the August 18, 2026 data cutoff, FT819 continues to demonstrate an encouraging safety profile across all 36 patients treated, 30 of whom had completed at least three months of follow-up (Regimen A, n=29; Regimen B, n=6; Regimen C, n=1).
Outpatient Administration
- 12 of 36 patients (33%) received FT819 as outpatient administration under two regimens in the FT819-102 clinical trial (Regimen A, n=9; Regimen B, n=3). Eight patients were discharged on the day of infusion and four the following day.
- The accumulated safety data in outpatient administration was comparable to inpatient hospitalization settings, including low and comparable grade ≥3 treatment-emergent adverse events within four days of the first dose occurring in 16.7% of both groups, and serious adverse events occurring in 8.3% of both groups. One outpatient developed Grade 2 cytokine release syndrome (CRS) on Day 4 requiring hospitalization, which resolved on Day 5 with tocilizumab and supportive care.
Regimen B: Treatment Without Conditioning Chemotherapy
- Regimen B is designed to remove key barriers that may keep patients with autoimmune disease from considering cell therapy: it eliminates the need for intensive conditioning chemotherapy that can be associated with severe adverse events and allows patients to remain on their background therapy.
- All three of the first extrarenal SLE patients treated under Regimen B achieved meaningful clinical responses, with two patients achieving Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission and one patient achieving Lupus Low Disease Activity State (LLDAS) as of last visit.
- Responses were maintained or deepened with longer follow-up:
- Patient 1, a 23-year-old woman with cardiorespiratory involvement, maintained LLDAS at Months 3, 6 and 9.
- Patient 2, a 35-year-old woman, treated as an outpatient, achieved Systemic Lupus Erythematosus Responder Index (SRI-4) at Months 3 and 6, and achieved DORIS remission at Month 9.
- Patient 3, a 43-year-old woman with a 24-year disease history, treated as an outpatient, achieved DORIS remission at Month 3. Month 6 had not yet been reached as of data cutoff.
- The encouraging clinical results seen in Regimen B of FT819 without any conditioning further supports the FT839 COMPLETE trial and the broader use of conditioning-free treatment regimens in autoimmune disease.
Fatigue Biomarker Correlation with Disease Activity
- FT819, with and without conditioning chemotherapy, drove clinically meaningful improvements in fatigue, one of the most debilitating and treatment-resistant symptoms of SLE. In patients with at least 6-months of follow-up (n=13), the median improvement was approximately 18 points by Month 6, more than four times the minimal clinically important difference, with many patients improving from moderate-to-severe fatigue to minimal or no fatigue.
- Key findings show elimination of expanded B-cell clones, rather than the depth of total peripheral B-cell depletion, was associated with durable fatigue improvement.
- Interestingly, reduced memory B cell activation is a specific biomarker for fatigue response, which may allude to why standard of care therapies do not promote significant improvement in fatigue scores in severe lupus disease.
Regimen C: Multi-Dose FT819 to Deepen Responses
Regimen C evaluates two doses of FT819, given on Day 1 and Day 15 after less-intensive fludarabine-free conditioning, with the intent to deepen and extend clinical responses. Unlike patient-specific CAR T-cell therapies which are limited to the manufacture of a few doses, FT819 is manufactured at large scale from a clonal master iPSC line, so additional doses are readily available off-the-shelf and are not cost prohibitive.
- The first patient treated under Regimen C, a 57-year-old man with three years of SLE and seven prior therapies, experienced a SLEDAI-2K score reduction from 10 at baseline to 2 by Day 29. The patient achieved SRI-4 at Day 29, LLDAS at Month 2, and was still in LLDAS at Month 3. The second dose was administered as outpatient.
- No Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) or Grade ≥3 adverse events were reported in the Regimen C patient.
- The Company expects to provide further updates on the multi-dose Regimen.
Regimen A: Renal Response in Lupus Nephritis Supports RECLAIM-LN
- 100% (2/2) of patients with active lupus nephritis treated with FT819 and bendamustine conditioning achieved complete renal response (CRR) or primary efficacy renal response (PERR) at Month 6. Mean urine protein-to-creatinine ratio (UPCr) fell 50% from baseline at Month 6, and the UPCr reduction was sustained through Month 24.
- Across both conditioning agents (cyclophosphamide or bendamustine), 50% (3/6) of patients with lupus nephritis achieved CRR or PERR at Month 6 after a single dose of FT819.
- These data support the ongoing RECLAIM-LN™ Phase 2 potentially registrational study of FT819 in patients with refractory, moderate-to-severe lupus nephritis.
FT839: Preclinical Data in Rheumatoid Arthritis
The Company presented preclinical data for FT839, its off-the-shelf, dual CD19 and CD38 co-targeting CAR T-cell product candidate in rheumatoid arthritis (RA). In complex autoimmune diseases, B-cell depletion alone leaves behind other immune cell populations that drive and sustain inflammation, including that in the joint of RA patients. The data presented at ACR exhibits the unique features of FT839 designed to eliminate inflammation often caused by a broad array of activated and proliferating immune cells while avoiding the need for conditioning chemotherapy.
- In mixed immune cell cultures, FT839 eliminated the full spectrum of B-cells, including plasmablasts and plasma cells. FT839 also selectively eliminated activated CD38-positive T, NK and myeloid cells while sparing their CD38-negative counterparts, supporting targeted activity against activated immune cells rather than broad immune depletion. The demonstrated activity also exhibited the unique ability to maintain activity in a mismatched setting, a reflection of the lack of requirement for conditioning chemotherapy.
- In a preclinical model of RA combining activated immune cells with inflammatory fibroblast-like synoviocytes, FT839 eliminated B cells, plasmablasts, activated T cells, NK cells and inflammatory macrophages, known contributors to the pathology of RA.
- FT839 retained its activity in the presence of commonly used DMARDs, including methotrexate, azathioprine and mycophenolic acid, supporting administration alongside stable background therapy.
- In an allogeneic resistance model, FT839 Sword & Shield™ technology enabled functional persistence and maintained elimination of B cells, activated host immune cells and product-reactive allogeneic T cells.
FT839 is being evaluated in COMPLETE™, a Phase 1/2 dose-escalation and dose-expansion basket study in patients with moderate-to-severe autoimmune diseases, including RA, which is open for enrollment.
SLE Patient Perspectives on Off-the-Shelf CAR T-cell Therapy
In collaboration with the Lupus Foundation of America (LFA), the Company presented focus group data on how people with moderate-to-severe SLE weigh the risks, benefits and requirements of FT819. Participants were recruited from LFA’s Research Accelerated by You (RAY®) registry and all five participants have active, severe SLE (mean age 40; mean disease duration 20 years).
- Participants unanimously preferred FT819’s off-the-shelf design over autologous CAR T-cell therapy, citing immediate access, shorter hospitalization, less-intensive conditioning and product consistency.
- Participants described a heavy treatment burden with significant unmet need for new medicine: two to four lupus medications plus 6 to 17 other medications, and seeing up to 12 physicians.
- Safety ranked as the top treatment priority for the majority of the participants. Interest in FT819 was high but conditional on a safety profile commensurate with efficacy.
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 FT839
FT839 is the Company’s first multi-antigen dual-CAR T-cell product candidate, designed to express two unique CARs: a first CAR targeting the B-cell lineage marker CD19 and a second CAR targeting the immune activation marker CD38, which is often found on aberrant T, NK and B cells. FT839 is a 13-point edited CAR T cell and the second program to incorporate the Company’s Sword & Shield™ technology. The FDA cleared the IND application for FT839 in July 2026, and the Company is conducting COMPLETE (FT839-101), a Phase 1/2 basket clinical trial evaluating FT839 across autoimmune indications in combination with standard-of-care therapy, without the requirement for conditioning chemotherapy.
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 master 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
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the advancement of and plans related to the Company’s product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the activation of clinical sites and the pace of patient screening, enrollment, and dosing, the manufacture, release, distribution and availability of drug product supply, including the Company’s expectations regarding the adequacy of drug product inventory to support clinical trial demand and the Company’s ability to manufacture its product candidates at scale, provide doses on demand and at a low cost of goods, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, and the Company’s progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities. These and any other forward-looking statements in this release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk that preliminary clinical results may change as additional patients are treated and additional data become available and may not predict results in larger or potentially registrational trials, the risk that preclinical results for FT839 may not be replicated in clinical studies, the risk that alignment with the FDA on potency or other CMC matters may not be maintained or may not result in acceptance of the Company’s approach at the time of a marketing application, the risk of a delay or difficulties in the manufacturing, release, or supply of the Company’s product candidates, including the risk that the Company may be unable to manufacture its product candidates at scale, on demand, or at the anticipated cost, or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that clinical site activation and patient screening, enrollment and dosing may not proceed as anticipated, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, risks relating to regulatory interactions and the outcome of such interactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
Contact:
Ryan Douglas
Fate Therapeutics, Inc.
IR@fatetherapeutics.com
