UPDATE: Phase 1 Trial Begins for Investigational 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, which is defined as lupus that is not characterized by Class III/IV glomerulonephritis and proteinuria and includes people who do not have LN). The researchers will provide updates as the study advances. 

CB-010 is an allogeneic cell therapy designed to target CD19, a protein on B cells that contributes to autoantibody production and lupus disease activity. Allogeneic cell therapy is a type of medical treatment where healthy cells from a donor are used to treat the patient. These donor cells are specially chosen to match the patient as closely as possible, though they are not the patient’s own cells. The therapy works by using these healthy cells to repair damaged tissues, fight diseases, or replace cells that the patient’s body can’t produce properly, such as in certain cancers or genetic disorders.

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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