The U.S. Food and Drug Administration has cleared (when a clinical study sponsor receives approval to administer an investigational drug or biological product to humans) an application for a new investigational therapy, FasTCAR-T GC012F, for treatment of refractory systemic lupus erythematosus. Researchers will initiate a Phase 1 / 2 clinical trial next year. 

Using CD19/BCMA dual-targeting CAR-T cell therapy, the drug 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 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. FasTCAR-T GC012F has demonstrated favorable response in people with other immune system related diseases, including multiple myeloma, and B-cell non-Hodgkin lymphoma. 

Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about treatments being studied for lupus.

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