Advancing Clinical Research for a CAR T-Cell Therapy for Systemic Lupus Erythematosus (SLE), Autoimmune Diseases

The California Institute for Regenerative Medicine (CIRM) has awarded $7.9 million to Barbara Hickingbottom, MD, of Fate Therapeutics to advance clinical research for FT819, an induced pluripotent stem cell (iPSC)-derived CD19 CAR T-cell therapy for Systemic Lupus Erythematosus (SLE).

SLE is a debilitating autoimmune disease and affects more than 200,000 Americans, particularly women of color.

FT819 targets B cells with the aim to reset the immune system and provide drug-free remission for patients with autoimmune diseases. Fate manufactures FT819 using a clonal master iPSC line as a renewal cell source, providing a uniform cell therapy product that is mass produced and delivered off-the-shelf to patients.

As a result, FT819 is designed to bring the curative potential of cell therapy to large numbers of patients with SLE and other autoimmune diseases.

"This innovative approach shows great promise in transforming clinical practice for Systemic Lupus Erythematosus, providing a new potential treatment option for individuals and families affected by this challenging disease," added Dr. Creasey.

"CD19 CAR T cell therapy has demonstrated tremendous potential for patients with autoimmune diseases," said Dr. Hickingbottom. "We look forward to partnering with CIRM to broadly realize this potential with FT819, the industry's first CAR T-cell therapy manufactured from a clonal master iPSC line to reach clinical investigation."