{"id":960719,"date":"2026-05-11T08:54:31","date_gmt":"2026-05-11T12:54:31","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/fate-therapeutics-showcases-ft819-clinical-activity-in-sle-without-the-use-of-conditioning-chemotherapy-at-the-2026-asgct-annual-meeting\/"},"modified":"2026-05-11T08:54:31","modified_gmt":"2026-05-11T12:54:31","slug":"fate-therapeutics-showcases-ft819-clinical-activity-in-sle-without-the-use-of-conditioning-chemotherapy-at-the-2026-asgct-annual-meeting","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fate-therapeutics-showcases-ft819-clinical-activity-in-sle-without-the-use-of-conditioning-chemotherapy-at-the-2026-asgct-annual-meeting\/","title":{"rendered":"Fate Therapeutics Showcases FT819 Clinical Activity in SLE without the use of Conditioning Chemotherapy at the 2026 ASGCT Annual Meeting"},"content":{"rendered":"
\n

\n Single dose treatment of FT819 without conditioning chemotherapy achieves lupus low disease activity state (LLDAS) in active SLE Patients; durable B cell remodeling is exhibited by depletion of major B cell clones up to 12 months following treatment with B cell shift towards less class-switched BCR repertoire<\/em>\n <\/p>\n

\n Preclinical data for FT839 demonstrate comprehensive targeting of multicellular disease across autoimmune and hematological malignancies; <\/em>data shows broad and selective depletion of pathogenic immune cell subtypes in rheumatoid arthritis and systemic lupus erythematosus disease without the use of conditioning chemotherapy<\/p>\n

\n Preclinical data for FT836 shows effective elimination of broad range of cancers in synergy with SOC treatments; radiotherapy and chemotherapy significantly enhance FT836 cytolytic activity and specific trafficking to the tumor site<\/em>\n <\/p>\n

SAN DIEGO, May 11, 2026 (GLOBE NEWSWIRE) — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies broadly to patients with cancer and autoimmune diseases, is presenting data this week featuring its off-the-shelf CAR T-cell programs FT819, FT839, and FT836 at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting to be held in Boston, MA, May 11\u201315, 2026.<\/p>\n

\u201cWe are excited to highlight our leadership in delivering off-the-shelf CAR T cells with less-intensive or no conditioning chemotherapy to ensure broad patient accessibility,\u201d said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. \u201cWith FT819, we are demonstrating that it is feasible to drive CAR T-cell efficacy with less-intensive or no conditioning chemotherapy in SLE and believe that eliminating the need for intensive conditioning chemotherapy has the potential to significantly improve the safety and clinical benefit of cellular therapies. With our next generation CAR T-cell programs, FT836 and FT839, we are illustrating that through precise multiplexed-engineering of iPSCs to generate clonal master banks that serve as the starting point for large scale manufacture of uniform and consistent drug product, it is feasible to tackle complex multicellular diseases, support functional persistence without the need for intensive conditioning chemotherapy, and create synergy with standard-of-care therapies to deliver effective treatments for patients with unmet need.\u201d<\/p>\n

\n Presentation Summaries Include:<\/strong>\n <\/p>\n

\n Title: FT819 Drives B cell Compartment Remodeling of Patients with Systemic Lupus Erythematosus Without Conditioning Chemotherapy; <\/strong>Poster Presentation Date \/ Time: Tuesday, May 12, 5:00 PM \u2013 6:30 PM ET<\/p>\n

FT819 is the Company\u2019s off-the-shelf, CD19-targeted, iPSC-derived CAR T-cell program, which is currently being investigated in a Phase 1 study for patients with moderate-to-severe systemic lupus erythematosus (SLE) including lupus nephritis and extrarenal lupus (NCT06308978). Data presented this week shows that in Regimen B of the Phase 1 study with a data cutoff of April 9, 2026, a single dose of FT819 without conditioning chemotherapy and in the presence of background therapy demonstrated meaningful clinical\u00a0responses\u00a0at dose level\u00a01 in patients with active SLE, with 3 of 3 patients achieving systemic lupus erythematosus responder index (SRI-4) and 2 of 3 patients achieving lupus low disease activity state (LLDAS). The positive clinical outcomes were\u00a0supported mechanistically by\u00a0the observation that\u00a0B cells in the periphery as well as in secondary lymphoid tissue (nasopharyngeal swabs)\u00a0were significantly depleted.\u00a0Notably, depletion\u00a0(79% on average)\u00a0of major B cell clones\u00a0(as defined by B cell receptor sequencing) were observed,\u00a0with the depletion\u00a0lasting up to 12 months following treatment.\u00a0Collectively, preliminary\u00a0data demonstrate\u00a0that treatment with FT819 without conditioning chemotherapy and in the presence of background therapy can drive comprehensive changes in B cell repertoire that\u00a0are associated\u00a0with clinical benefit, alongside a favorable safety profile.\u00a0Patient treatment at the higher dose of 900 million cells (dose level 2) has been initiated.<\/p>\n

\n Title: FT839: A Multi-Antigen Targeting Off-the-Shelf dual-CAR T cell for the Treatment of Pathogenic B and T Cells in Autoimmune Diseases; <\/strong>Oral Presentation Date \/ Time: Thursday, May 14, 8:30 AM – 8:45 AM ET<\/p>\n

FT839 is a next generation, off-the-shelf dual CAR T-cell therapy targeting CD19 and CD38 to deplete multiple pathogenic immune cell populations that drive hematological and complex autoimmune diseases, including rheumatoid arthritis (RA), type I diabetes, and multiple sclerosis. Preclinical data to be presented show broad, selective depletion of pathogenic immune cell subtypes in RA and SLE disease samples, including over 99% of B cells, plasmablasts, and plasma cells and more than 90% of activated CD4+ and CD8+ T cells, while sparing non-activated T cells, which comprise most of the endogenous T-cell population. The presentation will also demonstrate that targeting capabilities of FT839 are further enhanced through synergistic pairing with standard-of-care (SOC) therapeutic monoclonal antibodies (mAb; e.g. rituximab) or clinically approved T-cell engagers (e.g. epcoritamab), to activate either the engineered Fc receptor, hnCD16, or the novel CD3 Fusion receptor, respectively, improving cytolytic activity by ~3.5-6x on CAR antigen negative targets. With Sword and ShieldTM<\/sup>\u00a0technology, FT839 persistence is enhanced ~60x compared to CAR T cells lacking Sword and ShieldTM<\/sup> engineering in HLA-mismatched allogeneic settings, while the generation and expansion of product-specific immune cell responses are severely blunted (~1\/900), thereby reducing the need for intensive\u00a0conditioning chemotherapy. Importantly, non-product specific T cells were spared. \u00a0FT839 is produced through a scalable and reproducible process that enables on-demand availability of a homogenous CAR T-cell therapy, overcoming key accessibility and safety limitations of autologous CAR T-cell therapies, selectively depleting disease-driving B lineage and activated T cells for the treatment of patients with complex autoimmune and hematological\u00a0diseases.<\/p>\n

\n Title: CAR T cells Targeting pan-Tumor Antigens MICA\/B can be Uniquely Combined with SOC Treatments without Conditioning Chemotherapy for Broad and Effective Therapeutic Application in Cancer; <\/strong>Poster Presentation Date \/ Time: Wednesday, May 13, 5:00 PM – 6:30 PM ET<\/p>\n

FT836 is a next generation, off-the-shelf CAR T-cell therapy that targets the novel and inducible pan-tumor antigens\u00a0MICA\/B.\u00a0 FT836 is engineered to enable rational combination with SOC therapeutics such as mAbs, chemotherapy, radiotherapy, and immune modulators across both hematological malignancies and solid tumor settings.\u00a0 Integrated engineered elements, including Sword and Shield\u2122\u00a0technology, support broader and more universal application without the requirements for conditioning chemotherapy. Preclinical data to be presented demonstrate potent and durable control of multiple solid and liquid xenograft tumor models of varying origin and antigen expression by FT836 activity as a monotherapy or in combination with mAbs, such as trastuzumab, cetuximab, or daratumumab (up to 100%\u00a0tumor control), underscoring its broad and universal therapeutic potential in cancer. FT836 also features Sword and Shield\u2122 technology, enabling improved persistence (~20-30x) and selective containment of product-specific immune cell responses (~5x product specific and ~1x nonspecific), thereby enabling clinical strategies that are not reliant on conditioning chemotherapy. FT836 is shown to be rationally combined with established SOC therapeutics, including chemotherapy or radiotherapy, that complement its unique mechanisms of action and engineering profile to specifically upregulate both MICA\/B (~2-3x) and the CXCR2 ligand CXCL8 (3-4X) expression, enhancing both the cytolytic activity (~5x)\u00a0 and specific trafficking\u00a0(~2-3x) of FT836. In addition, FT836 is compatible with multiple myeloma standard of care therapeutics such as Bortezomib and Lenalidomide which further enhances the cytolytic activity of FT836 (1.25x + lenalidomide). Collectively, these data demonstrate the broad utility of FT836 and its ability to rationally combine with SOC therapeutic agents without the need for conditioning chemotherapy, supporting expanded patient access across both hematological and solid tumor indications. FT836 is currently being evaluated clinically in advanced solid tumor patients in combination with the trastuzumab and cetuximab (NCT07216105) and in relapsed and\/or refractory multiple myeloma in combination with daratumumab (NCT07221032).<\/p>\n

\n About\u00a0Fate Therapeutics, Inc.<\/strong>
\n
Fate Therapeutics\u00a0is 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\u2019s 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.\u00a0Fate Therapeutics\u00a0is headquartered in\u00a0San Diego, CA.\u00a0For more information, please visit\u00a0www.fatetherapeutics.com<\/a><\/p>\n

\n About FT819<\/strong>\n <\/p>\n

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 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.\u00a0FT819 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 number: CLIN2-16303)<\/p>\n

\n Forward-Looking Statements<\/strong>\n <\/p>\n

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company’s product candidates, clinical studies and preclinical research and development programs, the Company\u2019s progress, plans and timelines for the clinical investigation of its product candidates, including the Company\u2019s plans to submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company\u2019s clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company\u2019s product candidates, the availability of data from the Company\u2019s clinical trials and the Company\u2019s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company\u2019s research and development programs and product candidates, the Company\u2019s clinical and product development strategy, and the Company\u2019s progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities, including its expectations relating to alignment with regulatory authorities on potential registrational pathways for FT819. 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\u2019s 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\u2019s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company\u2019s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, 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\u2019s 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\u2019s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company\u2019s 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), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and 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\u2019s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company\u2019s periodic filings with the Securities and Exchange Commission, including but not limited to the Company\u2019s most recently filed periodic report, and from time to time in the Company\u2019s press releases and other investor communications.\u00a0Fate Therapeutics\u00a0is 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.<\/p>\n

Ryan Douglas
Fate Therapeutics, Inc.
IR@fatetherapeutics.com<\/a><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Single dose treatment of FT819 without conditioning chemotherapy achieves lupus low disease activity state (LLDAS) in active SLE Patients; durable B cell remodeling is exhibited by depletion of major B cell clones up to 12 months following treatment with B cell shift towards less class-switched BCR repertoire Preclinical data for FT839 demonstrate comprehensive targeting of multicellular disease across autoimmune and hematological malignancies; data shows broad and selective depletion of pathogenic immune cell subtypes in rheumatoid arthritis and systemic lupus erythematosus disease without the use of conditioning chemotherapy Preclinical data for FT836 shows effective elimination of broad range of cancers in synergy with SOC treatments; radiotherapy and chemotherapy significantly enhance FT836 cytolytic activity and specific trafficking to the tumor site SAN … <\/p>\n

Continue reading “Fate Therapeutics Showcases FT819 Clinical Activity in SLE without the use of Conditioning Chemotherapy at the 2026 ASGCT Annual Meeting”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-960719","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nFate Therapeutics Showcases FT819 Clinical Activity in SLE without the use of Conditioning Chemotherapy at the 2026 ASGCT Annual Meeting - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/fate-therapeutics-showcases-ft819-clinical-activity-in-sle-without-the-use-of-conditioning-chemotherapy-at-the-2026-asgct-annual-meeting\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fate Therapeutics Showcases FT819 Clinical Activity in SLE without the use of Conditioning Chemotherapy at the 2026 ASGCT Annual Meeting - 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