Fate Therapeutics Announces Data Presentation of FT819 Off-the-Shelf CAR T-Cell Product Candidate for Systemic Lupus Erythematosus (SLE) at the CCR – East 2026 Meeting
The Company is participating in a Poster Rounding Session and will present an encore of its clinical data from the systemic lupus erythematosus (SLE) study arm of its ongoing Phase 1 trial evaluating FT819 in various autoimmune diseases. The presentation includes clinical safety, efficacy and translational data from 13 SLE patients with a data cutoff of
Highlights of the presentation include data from the first 10 SLE patients treated in Regimen A illustrating clinically meaningful improvements in disease activity and patient-reported outcome measures following a single dose treatment of FT819 combined with less-intensive fludarabine-free conditioning chemotherapy, among patients with at least 1 month of follow-up. These response were observed early and were maintained over time, as demonstrated by, i) SLEDAI-2K: Scores decreased by 13 points from baseline at Month 6 (mean ± SEM), ii) PGA: Scores decreased by 1.75 points from baseline at Month 6 (mean ± SEM); iii) UPCr: Levels decreased by 0.90 and 1.14 mg/mg from baseline at Months 3 and 6, respectively (mean ± SEM), and iv) FACIT-Fatigue: Scores improved by 23.4 ± 5.98 and 24.3 ± 3.07 points from baseline at Months 3 and 6, respectively (mean ± SEM).
Poster Presentation
Title: Safety and Efficacy of an Off-the-Shelf Anti-CD19 CAR T-Cell Therapy with Reduced Conditioning in SLE: A Phase 1 Study
Session: CCR-East Faculty Poster Rounding Session
Presentation Date / Time: Friday, May 1, 2026 / 2:55 p.m. to
About
About FT819
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. 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)
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.
Contact:
IR@fatetherapeutics.com
Source: Fate Therapeutics, Inc.