Fate Therapeutics Receives FDA Clearance of Investigational New Drug Application for FT839 Product Candidate
First-of-Kind, Dual-CAR T cell Targeting CD19 and CD38 for Comprehensive Elimination of Complex, Multi-System Autoimmune Disorders Advances into Phase 1/2 Clinical Development
Novel 13-point edited CAR T cell Built with a Suite of Genetic Edits and Manufactured as a Uniform Drug Product to Support Clinical Safety and Durable Efficacy in Autoimmune and Hematological Malignancies
SAN DIEGO, July 09, 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 disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for FT839, the Company’s next-generation, off-the-shelf CAR T-cell product candidate uniquely engineered to co-target CD19 and CD38. 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.
"FDA clearance of the FT839 IND is an important milestone that expands our off-the-shelf, iPSC-derived CAR T-cell platform capabilities for the comprehensive treatment of autoimmune disease, including rheumatoid arthritis," said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. "By co-targeting CD19 and CD38, FT839 is uniquely engineered to eliminate the full spectrum of aberrant, disease-driving immune cells, including B cells, plasma cells, and activated T cells, that are often the foundation of multicellular disease found in many autoimmune disorders as well as in hematological malignancies. In addition to the incorporation of multiple genetic edits to enhance performance and safety of the drug product, FT839 also includes our patented Sword & Shield™ technology which is designed to support durable activity without dependence on conditioning chemotherapy. The remarkably homogenous profile of FT839, a 13-point edited CAR T cell, is a testament to our distinct ability to genetically engineer cells and is enabled by our iPSC master cell bank platform where we have pioneered the ability to manufacture multiplex-engineered CAR T cells in a uniform and consistent manner at large scale for on-demand availability. We look forward to initiating the basket portion of this exciting Phase 1/2 study across multiple autoimmune indications and to advancing a truly accessible treatment option for patients in need."
FT839 is the Company’s second CAR T-cell product candidate to advance into clinical development for autoimmune disease, joining FT819, an off-the-shelf, CD19-targeted CAR T-cell candidate currently entering Phase 2 development in a potentially registrational trial in lupus nephritis. FT839 is designed to broaden the reach of off-the-shelf CAR T-cell therapy beyond B-cell depletion by simultaneously targeting CD19 and CD38. The elimination of B-lineage cells, including plasma cells, and CD38-expressing activated and proliferating immune cells (e.g. T cells, macrophages and NK cells) is expected to support comprehensive immune rebalancing across a diverse spectrum of autoimmune conditions. FT839 immune cell targeting can be further extended in combination with approved therapeutic monoclonal antibodies or T-cell engagers. Additionally, the Phase 1/2 trial design allows for accelerated development opportunities by avoiding the gap between separate Phase 1 and Phase 2 trials and is intended to enable assessment of both safety and efficacy data in a single trial.
FT839 has been engineered with 13 targeted genetic edits that together confer multi-antigen targeting, immune evasion, and enhanced functional persistence, and that are designed to overcome key limitations of autologous patient-derived and allogeneic donor-derived CAR T-cell therapy, including manufacturing complexity, high cost, limited on-demand availability, and the requirement for intensive conditioning chemotherapy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master iPSC bank serves as the starting cell source to manufacture FT839, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT839 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.
FT839 multiplexed engineering includes the following functional elements:
- Dual CD19 and CD38 chimeric antigen receptors (CARs) to eliminate aberrant and pathogenic immune cells such as B cells, plasma cells, macrophages and activated T cells, as well as hematologic cancer cells of lymphoma, leukemia, and myeloma origin.
- High-affinity, non-cleavable CD16 (hnCD16) Fc receptor to maximize antibody-dependent cellular cytotoxicity (ADCC) in combination with approved therapeutic monoclonal antibodies (for example, rituximab or obinutuzumab), extending coverage against antigen-heterogeneous and antigen-escape populations.
- CD3ε Fusion Receptor (CD3FR) to support T-cell engager (TCE)–driven activation in combination with approved bispecific engagers (for example, epcoritamab, teclistamab or talquetamab).
- Sword & Shield™ technology (comprising an Alloimmune Defense Receptor and a CD58 genetic knockout) to selectively eliminate and evade host allogeneic immune responses, promote functional persistence, and thereby avoid the need for conditioning chemotherapy.
- Synthetic chemokine receptor CXCR2 and a TGFβ signal redirection receptor (TGFβ SRR) to improve trafficking to sites of pathological activity and to counter the immunosuppressive effects of the tissue microenvironment.
- CD38 and TRAC genetic knockouts to enhance metabolic fitness and safety profile by avoiding the risk of graft versus host disease in allogeneic setting, respectively.
In preclinical studies, including data presented at the 2026 American Society of Gene and Cell Therapy (ASGCT) and at the European Congress of Rheumatology (EULAR) Annual Meetings, FT839 selectively eliminated autoimmune disease drivers such as B cells, plasma cells, and activated T cells, as well as hematologic cancer cells, both as monotherapy through its dual CARs and in combination with therapeutic monoclonal antibodies and T-cell engagers. In allogeneic settings, Sword & Shield™ technology supported enhanced persistence and durable activity of FT839 without conditioning chemotherapy.
The Phase 1/2 study consists of a multi-indication basket trial designed to evaluate the safety, tolerability, and preliminary activity of FT839 administered in combination with standard-of-care therapy, with or without the use of conditioning chemotherapy, in patients with autoimmune disease. 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.
The company also plans to investigate the activity of FT839 in other autoimmune diseases, including Type 1 diabetes and multiple sclerosis, through investigator-initiated trials. Beyond autoimmune disease, the Company believes the dual-CAR mechanism of FT839 and ability to combine with therapeutic monoclonal antibodies and T-cell engagers also support its potential in hematologic malignancies, including B-cell lymphomas, leukemias, and multiple myeloma.
About FT839
FT839 is the Company’s first multi-antigen dual-CAR T-cell product candidate that is designed to express two unique CARs: a first CAR targeting the B-cell lineage marker CD19 and the second CAR targeting the immune activation marker CD38, which is often found on aberrant T, NK and B cells. FT839 is the second product candidate to contain the Company’s Sword and ShieldTM technology. 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.
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
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 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, including the Company’s plans to complete IND-enabling activities and submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, 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 clinical, 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, including its expectations relating to alignment with regulatory authorities on potential registrational pathways for FT839 and 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’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 of a delay or difficulties in the manufacturing of the Company’s 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’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), 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’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.
Ryan Douglas
Fate Therapeutics, Inc.
IR@fatetherapeutics.com
