Investigational New Drug Application for ATA3219 Submitted to the FDA for Lupus Nephritis Treatment
A new drug application for the investigational therapy, ATA3219, for treatment of systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis) has been submitted to the U.S. Food and Drug Administration.
ATA3219 is a CAR-T cell therapy. CAR-T cell therapy depletes disease-causing antibody producing cells and B cells (immune system cells involved in the production of autoantibodies and lupus disease activity). CAR-T cells are genetically-modified T-cells. T-cells are part of the immune system. To make CAR-T cells, scientists create or engineer new cells called chimeric antigen receptors (CARs), and then introduce T-cells into them. ATA3219 uses T-cells from other individuals (allogeneic) to target CD19, a protein found on the surface of B cells, and produces autoantibodies.
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