Fate Therapeutics Presents New FT819 Data at ACR Convergence 2026 Highlighting Meaningful Clinical Responses in Lupus Without the Use of Conditioning Chemotherapy
Key Highlights
- ➤FT819 delivered responses in all three extrarenal lupus patients without conditioning chemotherapy
- ➤Two extrarenal lupus patients achieved DORIS remission; one achieved LLDAS
- ➤FT819 treated 36 patients with favorable safety and no dose-limiting toxicities
- ➤FT839 COMPLETE Phase 1/2 basket trial open for autoimmune disease enrollment
- ➤FT839 preclinical model eliminated activated immune cells across rheumatoid arthritis pathways
Expert Statements
Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics
“Our recent clinical data presented at ACR continues to show that FT819 can be delivered in a safe and effective manner that fits into routine rheumatology care.”
Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics
“Across 36 patients, we have seen favorable tolerability with approximately one-third of patients having now received FT819 as outpatient therapy with many discharged on the same-day.”
Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics
“We are also observing encouraging early clinical activity without the use of conditioning chemotherapy, which, when combined with a true off-the-shelf CAR T-cell manufacturing process, presents an opportunity to safely treat a larger population of patients.”
Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics
“Achieving DORIS remission and LLDAS in patients without the use of conditioning chemotherapy also provides valuable clinical insight as we advance FT839, our dual-CAR T cell co-targeting CD19 and CD38 for broad elimination of activated immune cells, to treat complex autoimmune diseases such as rheumatoid arthritis without the reliance on conditioning chemotherapy.”
Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics
“Moreover, early clinical evaluation of FT819 multi-dose regimen designed to deepen responses, is yielding encouraging outcomes.”
Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics
“Our multi-dose regimens are made feasible by our distinct ability to manufacture CAR T-cells at scale, which reduces supply constraints and enables on-demand dosing at a low cost of goods.”
Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics
“Lastly, we highlight that patients have consistently informed us that immediate access, shorter hospital stays and lighter conditioning matter most to them, and those are the precise attributes we have built into RECLAIM-LN, our Phase 2 potentially registrational trial in LN, as well as in our other CAR T-cell clinical programs.”
Updated safety data of 36 patients treated with FT819 across three regimens and four autoimmune disease indications with no dose-limiting toxicities continues to be favorable
100% (3 of 3) of extrarenal lupus patients treated with FT819 without the use of conditioning chemotherapy experienced measurable responses with two patients achieving the Definition of Remission in Systemic Lupus Erythematosus (DORIS) and the third achieving Lupus Low Disease Activity State (LLDAS)
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