FT819

FT819 is an investigational, off-the-shelf, allogeneic chimeric antigen receptor T-cell (CAR-T) therapy derived from induced pluripotent stem cells (iPSCs). It is engineered to target CD19 and incorporates a novel 1XX CAR construct integrated into the T-cell receptor α constant (TRAC) locus, which enhances efficacy and eliminates the risk of graft-versus-host disease by nullifying endogenous TCR expression. FT819 is designed for consistent manufacturing from a renewable master cell bank. The therapy exhibits rapid and deep depletion of pathogenic CD19+ B cells, tissue infiltration, immune reset with reconstitution favoring naïve/immature B cells over memory/plasmablasts, and does not require fludarabine conditioning. It is being developed primarily for moderate to severe systemic lupus erythematosus (SLE), including lupus nephritis and extrarenal lupus. Fate Therapeutics is developing FT819; it has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation and is currently in phase 1 clinical trials.

Other names

induced pluripotent stem cell-derived gamma-delta T cellsiPSC-derived gamma-delta CAR-T cellsCD19-targeting iPSC-derived gamma-delta T cellsCD-19-targeting iPSC-derived gamma-delta T cellsCD 19-targeting iPSC-derived gamma-delta T cellsγδ CAR-iTiPSC-derived γδ CAR-T cell therapy