UPDATE: Phase 1 Trial Begins for Investigational CAR-T Therapy, CB-010, for Lupus Nephritis Treatment

The Phase 1 GALLOP study evaluating investigational therapy, CB-010, for treatment of lupus nephritis (LN) has officially started. This open label, multicenter study will assess a single infusion of CB-010 in adults with LN, including those with extrarenal lupus (ERL, when LN symptoms affect other parts of the body). The researchers will provide updates as the study advances. 

CB-010 is a CAR-T cell therapy designed to target CD19, a protein on B cells that contributes to autoantibody production 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. CB-010 also features a unique modification that removes the PD-1 protein, which helps boost its performance in targeting lupus-affected cells. 

Additionally, the GALLOP study includes a partial human leukocyte antigen (HLA) matching process, which could improve how well the treatment works. The U.S. Food and Drug Administration (FDA) has granted CB-010 Fast Track designation, recognizing its potential as an innovative treatment for lupus that is difficult to manage. 

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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