Fate Therapeutics to Present Preliminary Clinical Data of FT819 Off-the-Shelf CAR T-Cell Product Candidate for Systemic Sclerosis at the ISSCR 2026 Annual Meeting
SAN DIEGO, July 06, 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 preliminary clinical data from the Company’s off-the-shelf CAR T-cell product candidate, FT819, will be presented at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting, being held at the Palais des congrès de Montréal in Montréal, Canada on July 8 - 11, 2026.
The Company is participating in the Clinical Trials Update oral session and will present on the Systemic Sclerosis (SSc) arm of its ongoing Phase 1 basket trial evaluating FT819 in various autoimmune diseases. The cohort is enrolling a treatment-refractory patient population, with eligibility requiring both prior treatment failure and ongoing active disease. The upper limit on disease duration for study entry was broadened to include patients with up to 15 years of disease duration, an intentional design choice to increase inclusivity while evaluating the therapy across a broader spectrum of patients.
Highlights of the presentation include data from the first four SSc patients treated as of the June 12, 2026 data cutoff. Three of the four patients were treated under Regimen A with less-intensive conditioning chemotherapy (cyclophosphamide or bendamustine alone) and one patient was treated under Regimen B with no conditioning chemotherapy. All participants demonstrated a Revised Composite Response Index in Systemic Sclerosis (rCRISS)25 or higher with meaningful mean improvement in the Modified Rodnan Skin Score (mRSS) at 3 months post treatment. The treatment was well tolerated with no Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Graft versus Host Disease (GvHD), hypogammaglobulinemia, or deaths reported in SSc participants on study. These data points reinforce the well-tolerated safety profile of FT819 and demonstrate encouraging clinical activity with the use of less-intensive or no conditioning chemotherapy, supporting its continued advancement as an off-the-shelf, on-demand, outpatient CAR T-cell therapy for SSc, an autoimmune disease with significant unmet need. FT819 is also being evaluated in Systemic Lupus Erythematosus (SLE) as part of the ongoing basket trial, with a Phase 2 potentially registrational trial planned in Lupus Nephritis.
Late-breaking Abstract Oral Presentation:
Title: Emerging Data with FT819: Favorable Tolerability and Clinical Activity in Systemic Sclerosis Using Off-the-Shelf IPSC-Derived Anti CD19 CAR T-Cells Without Fludarabine
Session: Clinical Trial Updates
Presentation Date / Time: Thursday, 9 July 2026, 9:45 AM EDT
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 number: CLIN2-16303)
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 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 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 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.
Contact:
Ryan Douglas
Fate Therapeutics, Inc.
IR@fatetherapeutics.com
