Fate Therapeutics gives Q3 2026 update on lupus CAR T program and FT839 trial sites
Fate said Phase 1 data presented at ASN Kidney Week showed full renal response in the bendamustine cohort informing its RECLAIM-LN Phase 2 study, while FT839 sites begin activating.
Fate Therapeutics reported financial results and a business update for the quarter ended September 30, 2026, in a release dated November 5, 2026.
The company said preliminary Phase 1 clinical data presented at ASN Kidney Week 2026 demonstrated 100% renal response in the bendamustine conditioning regimen selected for RECLAIM-LN.1 In that cohort, patients with active lupus nephritis treated with FT819 and bendamustine conditioning who had Month 6 follow-up, two patients, achieved a complete renal response or primary efficacy renal response, and mean urine protein-to-creatinine ratio decreased by approximately 50% from baseline.1 The complete renal response was sustained through Month 24 in the single patient who reached that timepoint.1
The company continues to advance RECLAIM-LN, a Phase 2 potentially registrational trial of FT819 in lupus nephritis, with enrollment currently open across 17 active sites.1 The open-label, single-arm study was developed following interactions with the FDA under the company's Regenerative Medicine Advanced Therapy designation, is expected to enroll approximately 53 patients, and will give patients a single dose of FT819 at 900 million cells following bendamustine conditioning, with complete renal response at Week 26 as the primary endpoint.1
Across the broader autoimmune program, safety data as of an August 18, 2026 data cutoff across all 29 autoimmune patients treated with a single dose of FT819 and less-intensive fludarabine-free conditioning showed no dose-limiting toxicities, no ICANS, no graft-versus-host disease, no IEC-HS, and no deaths.1
For FT839, the FDA cleared the company's IND application in July.1 The company has now activated multiple clinical sites, reflecting strong investigator interest, and expects to dose patients by year-end, including in rheumatoid arthritis.1
The California Institute for Regenerative Medicine awarded the company a $15.0 million grant through its CLIN2 program to support the clinical development of RECLAIM-LN.1
On financials, cash, cash equivalents, and investments as of September 30, 2026, were $139.1 million, a quarterly decrease of $14.7 million.1 Combined with the newly awarded CIRM grant, the company said this extends its cash runway to mid-2028.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.