Fate Therapeutics Announces Encore Clinical Data Presentation of FT819 Off-the-Shelf CAR T-Cell Product Candidate at the CCR – West 2026 Meeting
Phase 1 FT819 data in lupus, including kidney outcome measures, is being used to support Fate’s potentially registrational RECLAIM-LN trial.
Rhea-AI Summary
Fate Therapeutics (FATE) will present encore Phase 1 clinical data for FT819, its off-the-shelf anti-CD19 CAR T-cell candidate, in systemic lupus erythematosus (SLE) at the CCR – West meeting on September 18, 2026.
The update covers 16 SLE patients in Regimen A, which uses a single FT819 dose with less-intensive, fludarabine-free conditioning; 13 patients had at least one month of follow-up as of the May 14, 2026 cutoff. No dose-limiting toxicities, no Grade ≥3 cytokine release syndrome, and no cases of ICANS, GvHD, or IEC-HS were observed, with infections and cytopenias described as low and manageable. FT819’s design combines a tuned CAR motif, targeted insertion into the TRAC locus and clonal-level engineering to support safety and product uniformity.
Clinically meaningful improvements were reported in SLE disease activity and fatigue scores, emerging early and persisting over time. In patients with active lupus nephritis at baseline, Month 6 urine protein-to-creatinine ratio decreased by 1.15 g/g across Regimen A and by 1.8 g/g in those receiving a single FT819 dose plus bendamustine, which the company views as a meaningful kidney outcome supporting its Phase 2 RECLAIM-LN trial.
Positive
- 16 SLE patients treated in Regimen A, 13 with ≥1-month follow-up as of May 14, 2026
- No dose-limiting toxicities, Grade ≥3 CRS, ICANS, GvHD, or IEC-HS reported in Regimen A
- Month 6 UPCr in active lupus nephritis decreased by 1.15 g/g across Regimen A
- Month 6 UPCr decreased by 1.8 g/g in patients given single-dose FT819 plus bendamustine
- Reported early and maintained improvements in SLEDAI disease activity and FACIT-fatigue scores
Negative
- None.
Key Figures
- SLE patients treated
- 16 patients
- Phase 1 Regimen A
- Patients with follow-up
- 13 patients
- At least one month of follow-up as of May 14, 2026
- Dose-limiting toxicities
- 0
- SLE patients treated in Regimen A
- Grade 3 or greater CRS
- 0 cases
- SLE patients treated in Regimen A
- ICANS, GvHD, and IEC-HS
- 0 cases
- SLE patients treated in Regimen A
- Month 6 UPCr decrease
- 1.15 g/g
- All patients treated in Regimen A with active lupus nephritis
- Month 6 UPCr decrease
- 1.8 g/g
- Single-dose FT819 with bendamustine
Previous Clinical trial Reports
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RECLAIM-LN began dosing lupus nephritis patients with FT819
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FT819 showed early systemic sclerosis activity with favorable safety findings
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Updated FT819 SLE data reported safety and durable clinical responses
-
FT819 produced B-cell depletion and durable responses in SLE patients
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Key Terms
ipsc-derived technical
car t-cell medical
icans medical
upcr medical
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SAN DIEGO, Sept. 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 to patients with cancer and autoimmune diseases, today announced clinical data from its off-the-shelf anti-CD19 CAR T-cell product candidate FT819, and 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.
The Company is presenting encore clinical data from the systemic lupus erythematosus (SLE) study arm of its ongoing Phase 1 trial in support of its advancing RECLAIM-LN trial, a Phase 2 potentially registrational trial in lupus nephritis (LN). The presentation includes clinical safety, efficacy and translational data from 16 SLE patients treated in Regimen A of the Phase 1 trial, which is evaluating a single dose of FT819 combined with less-intensive, fludarabine-free conditioning chemotherapy, of whom 13 patients have completed at least one month of follow-up as of May 14, 2026 data cutoff.
Highlights of the FT819 presentation include:
- Favorable Tolerability: Among SLE patients treated in Regimen A, there were no dose-limiting toxicities, no cytokine release syndrome of Grade 3 or greater, and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD), or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). In addition, low and manageable rates of infection and cytopenia were observed.
- Designed for Safety: In addition to the use of less-intensive conditioning, which is intended to reduce the frequency of adverse events associated with lymphodepletion, FT819 incorporates multiple design attributes intended to support a favorable safety profile, including the combination of a novel tuned CAR motif and targeted insertion into the TRAC locus designed to prevent uncontrolled T-cell expansion, and precise engineering at the clonal level with a well-vetted master cell bank serving as the consistent starting point for routine manufacture to ensure drug product uniformity and reliability. Combined, these attributes incorporated at the molecular-, manufacture- and clinical-level are designed to provide a unique, planned advantage, with the goal of treating patients with CAR T cells in an effective yet safe manner.
- Early and Maintained Efficacy: As of the cutoff date, clinically meaningful improvements were observed in lupus disease activity and patient-reported outcome measures, including Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue scores, in patients treated in the Phase 1 trial. Improvements were observed early following treatment with FT819 using less-intensive conditioning therapy in Regimen A (≥1-month follow-up) and were maintained over time.
- Phase 1 Data Applicable to RECLAIM-LN: Month 6 UPCr levels in patients with active LN at baseline decreased by 1.15 g/g in all patients treated in Regimen A and, specifically, decreased by 1.8 g/g in patients treated with a single dose of FT819 and bendamustine, representing a meaningful therapeutic mark in the management of kidney disease.
FT819 Presentation
Title: Safety and Efficacy of an Off-the-Shelf Anti-CD19 CAR T-Cell Therapy with Reduced Conditioning in SLE Supporting Same-Day Discharge
Presentation Date / Time: Friday, September 18, 2026, at 3:40 p.m. PT
FT839 Presentation
Title: Off-the-Shelf Dual-CAR T-Cell Therapy: Targeting B and T Cells in Autoimmune Disease Without Preconditioning
Presentation Date / Time: Friday, September 18, 2026, at 3:40 p.m. PT
Presentation materials will be available following the event on the Fate website located here: Fate Publications & Presentations
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. 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
FAQ
What is Regimen A in the FT819 Phase 1 lupus study?
Regimen A evaluates a single dose of FT819 combined with less-intensive, fludarabine-free conditioning chemotherapy. This approach is intended to reduce the frequency of adverse events typically associated with lymphodepletion while enabling treatment with the off-the-shelf CAR T-cell product.
How is FT819 designed to support a favorable safety profile?
FT819 incorporates several design elements that the company says are intended to support safety: a novel tuned CAR motif, targeted insertion of the CAR into the TRAC locus to help prevent uncontrolled T-cell expansion, and precise clonal-level engineering from a well-vetted master cell bank to promote uniform, reliable manufacture.
How are the Phase 1 FT819 data being used to support the RECLAIM-LN trial?
Data from the SLE arm of the Phase 1 trial, including safety findings and Month 6 urine protein-to-creatinine ratio reductions in patients with active lupus nephritis, are being used to support RECLAIM-LN, a Phase 2 potentially registrational trial in lupus nephritis.
When and where will the FT819 and FT839 presentations take place?
Both the FT819 and FT839 presentations are scheduled for Friday, September 18, 2026, at 3:40 p.m. PT at the Congress of Clinical Rheumatology West (CCR – West) meeting in Huntington Beach, California.
What is FT839 and what will be presented at CCR – West?
FT839 is an off-the-shelf dual-CAR T-cell product candidate targeting B and T cells in autoimmune disease without preconditioning. Pre-clinical data will be presented under the title “Off-the-Shelf Dual-CAR T-Cell Therapy: Targeting B and T Cells in Autoimmune Disease Without Preconditioning.”
Where can investors and clinicians access the presentation materials?
Presentation materials for FT819 and FT839 will be made available after the event on Fate Therapeutics’ website under the Fate Publications & Presentations section.