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Investigational Therapy AlloNK Receives FDA Fast Track Status for Lupus Nephritis Treatment

by | Feb 26, 2024

Inside Lupus Research (ILR): Treatment News

The Food & Drug Administration (FDA) has granted Fast Track designation to the investigational therapy, AlloNK® (also known as AB-101), to be used in combination with rituximab or obinutuzumab, as a possible treatment for lupus nephritis, (LN, lupus-related kidney disease). 

AlloNK is a type of therapy made from natural killer (NK) cells, which are part of the immune system. It is designed to boost the efficacy of B-cell targeting monoclonal antibodies used in treating diseases like lupus nephritis and reduces the quantity of immune system cells involved in the production of autoantibodies and lupus disease activity. Unlike some other treatments, AlloNK is stored frozen and can be administered without complicated follow-up procedures. The therapy’s design is made without genetic changes, and does not carry the cancer risk associated with some CAR-T cell therapies. The treatment is currently undergoing Phase 1 , open-label study in people with LN who have not responded to or relapsed following standard therapy. 

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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