The U.S. Food & Drug Administration has granted approval for a Phase 1 study to evaluate the safety and efficacy of investigational therapy, CB-010, for treatment of lupus nephritis (LN). The GALLOP study will begin by year-end and will also be evaluated for people with extrarenal lupus (when LN symptoms affect other parts of the body).
CB-010 is a CAR-T cell therapy. CAR-T cell therapy targets B cells, which are immune system cells involved in the production of autoantibodies and lupus disease activity. To make CAR-T cells, scientists create or engineer new cells called chimeric antigen receptors (CARs), and then introduce T-cells into them. CB-010 targets CD19, a protein found on the surface of B cells, and produces autoantibodies and uses a person’s own immune T-cells. Additionally, researchers have engineered CB-010 cells to lack the PD-1 protein to bolster CAR-T cell performance.
The therapy has already shown encouraging results in people with relapsed or refractory 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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