FT839 / Fate Therapeutics - LARVOL DELTA

Fate Therapeutics, Inc…announced…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 (CCR – West) meeting, being held in Huntington Beach, CA on September 17-20, 2026. (GlobeNewswire)

Preclinical • Immunology

FT839: An Off-the-Shelf, Dual CAR T-Cell Therapy for the Comprehensive Elimination of Multicellular Drivers of Rheumatoid Arthritis (ACR Convergence 2026) - No abstract available

CAR T-Cell Therapy • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

FT839 in Autoimmune Diseases (clinicaltrials.gov) - P1/2 | N=446 | Recruiting | Sponsor: Fate Therapeutics

New P1/2 trial • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Fate Therapeutics Receives FDA Clearance of Investigational New Drug Application for FT839 Product Candidate (GlobeNewswire) - "With IND clearance, the Company plans to advance FT839 into a basket clinical trial intended to evaluate the product candidate across a range of autoimmune diseases when administered in combination with standard-of-care therapy and without dependence on conditioning chemotherapy. Enrollment in the Phase 1/2 study is expected to commence in the second half of 2026....The initial autoimmune indications to be evaluated in the trial are: Rheumatoid arthritis, ANCA-associated vasculitis, Idiopathic inflammatory myositis, Systemic lupus erythematosus with or without nephritis, and Systemic sclerosis."

IND • New P1/2 trial • ANCA Vasculitis • Myositis • Rheumatoid Arthritis • Systemic Lupus Erythematosus • Systemic Sclerosis

Title: Off-the-Shelf Dual-CAR T-Cell Therapy: Targeting B and T Cells in Autoimmune Disease Without Preconditioning (GlobeNewswire) - "In cytotoxicity assays against healthy donor and rheumatoid arthritis patient peripheral blood mononuclear cells (PBMCs), FT839 selectively eliminated CD19+CD38+/− B cells, CD19lowCD38+ plasmablasts, CD19−CD38+ plasma cells, and CD38+ activated CD4+ and CD8+ T cells, while demonstrating no cytotoxicity against non-activated, CD38-negative T cells — preserving the host’s non-pathogenic immune compartment...Sword and Shield engineering enabled FT839 to specifically suppress the emergence of alloreactive CD25+4-1BB+ T cells while sustaining CD19 and CD38 cytotoxicity in allogeneic settings; Depth of activity was further enhanced when combined with a CD20-specific mAb (activating hnCD16 Fc receptor) or a CD20-specific T-cell engager (activating CD3 fusion receptor), demonstrating the potential combinability of FT839 with standard-of-care biologics."

Preclinical • Immunology

Off-the-Shelf Dual-CAR T-Cell Therapy: Targeting B and T Cells in Autoimmune Disease Without Preconditioning (EULAR 2026) - "Objectives FT839 is an off-the-shelf, multi-point engineered dual-CAR T-cell product targeting both lineage and disease state cells, developed to overcome the single antigen targeting limitation of existing autologous T-cell products, eliminate the need for CCT, and expand therapeutic delivery, application, and safety to enable expanded reach in diverse autoimmune disease treatment settings...Its scalable, cost- effective, and consistent manufacturing process and off-the-shelf delivery supports broad clinical accessibility, thereby extending applicability across a range of diverse B and T-cell driven autoimmune diseases. Image(s), graphic(s), or table(s)"

CAR T-Cell Therapy • IO biomarker • CNS Disorders • Diabetes • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Leukemia • Lupus • Lymphoma • Metabolic Disorders • Multiple Sclerosis • Myasthenia Gravis • Psoriatic Arthritis • Rheumatoid Arthritis • Seronegative Spondyloarthropathies • Systemic Lupus Erythematosus • Type 1 Diabetes Mellitus • CD19 • CD20 • CD4 • CD58 • CD8 • IL2RA

FT839: A multi-antigen targeting off-the-shelf dual-CAR T cell for the treatment of pathogenic B and T cells in autoimmune diseases (ASGCT 2026) - "Figure Legend Figure 1. UMAP representations of flow cytometry profiling data from activated healthy donor PBMCs show selective loss of immune cell subsets expressing CD19, CD38, or both after 72 hours of FT839 co-culture."

CAR T-Cell Therapy • IO biomarker • Diabetes • Hematological Malignancies • Immunology • Inflammatory Arthritis • Leukemia • Lymphoma • Metabolic Disorders • Rheumatoid Arthritis • Type 1 Diabetes Mellitus • CD19 • CD4 • CD58 • CD8 • IL2RA

FT839: Next-generation Off-the-Shelf CAR T-cell Program Designed to co-target CD19 and CD38 and Armed with Novel Sword & Shield Technology Designed to Eliminate the Need for Conditioning Chemotherapy (GlobeNewswire) - "The Company plans to submit an Investigational New Drug (IND) application to the FDA to support a Phase 1 basket autoimmune study to evaluate FT839 in combination with standard of care therapies across SLE, SSc, AAV, IIM, and rheumatoid arthritis (RA), including without the use of conditioning chemotherapy, and expects to commence enrollment in the Phase 1 study in the second half of 2026...FT839 preclinical data in autoimmune disease are expected to be presented at the 2026 American Society of Gene and Cell Therapy Annual Meeting and at the 2026 EULAR Annual Congress...The Company will provide further updates on FT839 at American Society of Gene and Cell Therapy Annual Meeting in May of 2026."

IND • Preclinical • Myositis • Rheumatoid Arthritis • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Fate Therapeutics…presenting data this week featuring its off-the-shelf CAR T-cell programs…FT839…at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting to be held in Boston, MA, May 11–15, 2026 (GlobeNewswire) - "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 • Immunology • Systemic Lupus Erythematosus

FT839: A next-generation, off-the-shelf CAR T cell uniquely engineered with a dual CAR system targeting CD19 and CD38 for the treatment of hematological malignancies and autoimmune diseases without conditioning chemotherapy (AACR 2026) - "The comprehensive targeting strategy and the depth of activity was further extended when combined with the monoclonal antibody (mAb) rituximab or the T cell engager (TCE) epcoritamab facilitated through the expression of high affinity/non-cleavable Fc receptor (hnCD16) and CD3ε fusion receptor (CD3FR), respectively (p<0.01). Armed with CD19 and CD38 targeting CARs and the ability to functionally combine with approved therapeutic mAbs and TCEs, FT839 selectively and uniquely eliminates heterogeneously populated disease-driving immune cells. Collectively, FT839 is a scalable, cost-effective, and uniform off-the-shelf CAR T-cell therapy for the broad treatment of hematological malignancies and autoimmune diseases."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Oncology • CD38 • CXCR2

Fate Therapeutics Announces Data Presentation of FT839 Next-Generation Off-The-Shelf CAR T-Cell Product Candidate for the Broad Treatment of Hematological Malignancies and Autoimmune Diseases Without the Need for Conditioning Chemotherapy at the AACR Annual Meeting (GlobeNewswire) - "The Company has been selected to participate in a poster presentation featuring preclinical data from FT839, its next generation, 13-point edited, off-the-shelf CAR T-cell product candidate for the broad treatment of hematological malignancies and autoimmune diseases."

Preclinical • Hematological Malignancies • Immunology • Oncology

FT839 preclinical data presented at 2025 ASH Annual Meeting demonstrates broad targeting capacity across autoimmune diseases and hematologic malignancies without the need for conditioning chemotherapy. (GlobeNewswire) - "At the 2025 ASH Annual Meeting, the Company presented preclinical data demonstrating the ability of FT839, with its dual-CAR mechanism and unique ability to synergize with monoclonal antibodies and T-cell engagers through its incorporated hnCD16 Fc receptor and CD3 fusion receptor, respectively, to specifically eliminate a variety of pathogenic immune cell types without requiring conditioning chemotherapy, suggesting its potential to broadly treat complex autoimmune diseases and hematologic malignancies. The Company has created the FT839 master cell bank and is completing IND-enabling activities to support initial clinical investigation of FT839 for the treatment of autoimmune diseases and hematologic malignancies in 2026."

Preclinical • Hematological Malignancies • Immunology

The development of FT839: An off-the-shelf CD19xCD38 dual-CAR T cell for the treatment of multiple myeloma (ASH 2025) - "In vitro cytotoxicity assays against MM cell lines RPMI-8226, OPM2, MM1.s and H929 demonstrated durable and potent cell cytotoxicity at low effector:target ratios, as a monotherapy with further deepening of response when combined with mAbs such as daratumumab or sarclisa, or T cell engagers such as teclistamab or talquetamab (exceeding 90% cytotoxicity in each case). Collectively, FT839 is engineered to eliminate cancer cells with broad and heterogenous antigen expression by a unique dual-CAR system and in combination with standard of care therapeutics, including mAbs and TCEs via hnCD16 and CD3-CFR transgenes, to overcome multiple challenges that have limited autologous CAR T-cell therapies in treating MM. Moreover, as an off-the-shelf CAR T-cell therapy, FT839 is intended for broad and on-demand access without the need for complicated and variable manufacturing processes or intense conditioning chemotherapy."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Multiple Myeloma

The development of an off-the-shelf CAR T-cell therapy co-targeting CD19 and CD38 for broad application in autoimmune disease (ASH 2025) - "These results demonstrate the unique ability of FT839 tofunctionally persist in an allogeneic and mismatched setting without the need for intensive conditioningchemotherapy.In summary, FT839 enables the simultaneous and selective elimination of multiple disease-drivingimmune cells without the need for supportive conditioning chemotherapy. Its scalable, cost-effectivemanufacturing and off-the-shelf delivery supports broad clinical accessibility across a range ofautoimmune disease settings."

CAR T-Cell Therapy • IO biomarker • CNS Disorders • Graft versus Host Disease • Immunology • Infectious Disease • Inflammatory Arthritis • Multiple Sclerosis • Rheumatoid Arthritis • Rheumatology • CD4 • CD58 • CD8

Development of next generation multi-antigen targeting off-the-shelf CAR T cells for conditioning-free treatment of B-cell lymphoma (ASH 2025) - "Indeed, in combination with the CD20-specific mAb rituximab or theCD38-specific mAb daratumumb, FT839 potently eliminated the mantle cell lymphoma cell line Jeko-1(97.8% CD20+, 54,888 rMFI) and Burkitt's lymphoma cell line RAJI (91.6% CD38+, 101,129 rMFI),respectively, highlighting the flexible and broad multi-antigen targeting of FT839 via CAR and hnCD16activation. Finally, FT839 maintained durable anti-tumor activity againstrepeat challenges with NALM6 tumor cells 1.17x p=ns) even in the presence of primed allogeneic PBMCsthat elicit potent reaction against mismatched cells.Compared to traditional CAR T-cells, FT839 demonstrates versatility in targeting cancer cells via multipleantigen-receptor activation pathways, enabling potent and flexible multi-antigen targeting for thesuccessful treatment of relapsed/refractory B cell lymphomas that is otherwise challenging to treatbecause of its heterogenous cellular composition. Furthermore, unlike autologous and allogeneic..."

CAR T-Cell Therapy • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Burkitt Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • CD20 • CD58

The Company has now generated a master iPSC bank for conducting IND-enabling studies and is currently evaluating opportunities for clinical investigation of FT839 in hematological malignancies and autoimmune disease in 2026. (Fate Therapeutics Press Release)

New trial • Hematological Malignancies • Immunology

Fate Therapeutics Reports Second Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "At the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting in May, the Company presented preclinical data demonstrating robust eradication of aberrant CD19+ B cells, CD38+ plasma cells, and CD38+ activated T cells by FT839....The Company...is currently evaluating opportunities for clinical investigation of FT839 in hematological malignancies and autoimmunity, beginning in 2026."

New trial • Preclinical • Hematological Malignancies • Immunology

Fate Therapeutics Reports First Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "Next-generation iPSC-derived CAR T-cell Programs:...FT839 Dual CAR T-cell Program: FT839 is the Company’s dual CAR T-cell product candidate that incorporates its novel Sword & Shield technology and is designed to express two unique CARs: a first CAR targeting CD19+ B cells, and a second CAR targeting additional disease-causing cells. At the ASGCT Annual Meeting in May, the Company plans to present preclinical data demonstrating iPSC-derived CAR T cells targeting CD19 and the cell-surface glycoprotein CD38 specifically eliminated a variety of malignant cell types, including CD19+ lymphoma and CD38+ multiple myeloma cell lines."

Preclinical • Multiple Myeloma