Upgrade to SI Premium - Free Trial

Fate Therapeutics reports clinical progress for FT819 lupus treatment

May 11, 2026 8:31 AM

Fate Therapeutics Inc. (NASDAQ: FATE) presented clinical data for its FT819 treatment at the American Society of Gene and Cell Therapy Annual Meeting, showing activity in systemic lupus erythematosus patients without requiring conditioning chemotherapy.

In the company's Phase 1 study, a single dose of FT819 achieved lupus low disease activity state in 2 of 3 patients with active systemic lupus erythematosus. All 3 patients achieved systemic lupus erythematosus responder index response at the first dose level. The treatment was administered without conditioning chemotherapy and alongside background therapy.

The clinical responses were accompanied by significant B cell depletion in peripheral blood and secondary lymphoid tissue. Major B cell clones were depleted by an average of 79%, with effects lasting up to 12 months following treatment. Patient treatment at a higher dose level of 900 million cells has begun.

FT819 is an off-the-shelf CD19-targeting CAR T-cell therapy derived from induced pluripotent stem cells. The company is investigating the treatment for patients with moderate-to-severe systemic lupus erythematosus, including lupus nephritis and extrarenal lupus.

The company also presented preclinical data for FT839, a dual CAR T-cell therapy targeting CD19 and CD38, and FT836, which targets MICA/B antigens. Both programs are designed to work without conditioning chemotherapy requirements.

Fate Therapeutics develops cellular immunotherapies using its iPSC platform for cancer and autoimmune diseases. The company is headquartered in San Diego.

Categories

Corporate News

Next Articles