FDA Approves Clinical Trial of New Therapy for Refractory Lupus

The U.S. Food and Drug Administration (FDA) has cleared a new investigational therapy for refractory lupus, or treatment-resistant lupus, for clinical trial study. A CAR-T cell therapy, IMPT-514 targets B cells (immune system cells involved in the production of autoantibodies and lupus disease activity). CAR T-cells are genetically altered cells and 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. IMPT-514 therapy uses T-cells that are designed with a CAR that instructs them to attack cells with proteins typically found in B-cells, specifically CD19 and CD20 which are associated with severe immune deficiency.

In an open-label Phase 1b/2 clinical trial, scientists will test the therapy on people with lupus who have received at least two types of standard lupus therapies and continue to exhibit active disease. The Phase 1b trial will test the therapy with people with lupus nephritis, (LN, lupus-related kidney disease) and the Phase 2 trial will examine the therapy on people with and without LN.

Continue to follow the Lupus Foundation of America for updates on IMPT-514 as well as other lupus clinical trials.

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