Fate Therapeutics Presents FT819 Lupus Trial Data at CCR West

Fate Therapeutics presented updated Phase 1 clinical data for its off-the-shelf CAR T-cell candidate, FT819, in systemic lupus erythematosus at the Congress of Clinical Rheumatology West meeting, showing a manageable safety profile and renal function improvements.

The findings were featured at the CCR West meeting in Huntington Beach, California, held on September 17 to 20, 2026, according to an investor relations release from Fate Therapeutics.

"The presentation includes safety, efficacy, and translational data from 16 systemic lupus erythematosus (SLE) patients treated in Regimen A of the Phase 1 trial," according to Fate Therapeutics.

Clinical Findings and Safety Profile

Out of the 16 systemic lupus erythematosus patients treated under Regimen A, 13 patients completed at least one month of clinical follow-up as of the May 14, 2026 data cutoff. The trial evaluated safety, efficacy, and translational metrics for the anti-CD19 cell therapy candidate.

According to the company's clinical update, safety outcomes showed no dose-limiting toxicities and no occurrences of Grade 3 or greater cytokine release syndrome. Additionally, the trial reported zero 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).

Observed rates of infection and cytopenia remained low and manageable throughout the reporting period.

Renal Function and Biomarker Metrics

The trial tracked urine protein-to-creatinine ratio (UPCr) levels at Month 6 in patients presenting with active lupus nephritis at baseline to gauge efficacy in renal involvement.

Data from the clinical release show that UPCr levels decreased by 1.15 g/g across all patients treated in Regimen A. In the specific subset of patients treated with a single dose of FT819 combined with bendamustine, the average decrease in UPCr reached 1.8 g/g.

Market Valuation and Pre-Clinical Pipeline

Alongside the clinical presentation for FT819, the conference showcased pre-clinical data for Fate Therapeutics' separate pipeline candidate, FT839.

In the public markets, Fate Therapeutics Inc (FATE) stock closed at $2.44, down 2.40% on September 9, 2026, according to Finnhub market data. The valuation reflects investor tracking of the company's early-stage cell therapy programs as clinical readouts progress through scientific meetings.