Investigational Therapy NKX019 for Lupus Nephritis Treatment Begins Screening Trial Participants

A multi-center clinical trial of investigational therapy, NKX019, for the treatment of lupus nephritis (LN, lupus-related kidney disease) is screening its first participant. The Ntrust-1 study is designed to initially enroll up to 12 participants with refractory LN who will receive the cell therapy on Days 0, 7 and 14 of the study. Some participants may also receive additional treatment cycles to restore response. 

NKX019 is a chimeric antigen receptor natural killer (CAR NK) cell therapy that targets CD19 positive B cells. NK cells are lymphocytes which help destroy infected and diseased cells in your body. NKX019 is engineered by collecting NK cells from healthy donor blood and modified with a CAR designed to target CD19, a protein found on the surface of B cells. 

The Food & Drug Administration has also approved a second open-label, multi-center clinical trial for the drug for autoimmune disease study. The Ntrust-2 study will examine efficacy of the therapy for the treatment of systemic sclerosis, myositis and vasculitis. Both trials will assess the safety of NKX019 in people living with autoimmune diseases, as well as the drug’s ability to enable long-term remission via a “reset” of the immune system through the elimination of pathogenic B cells. 

Clinical data from Ntrust-1 and Ntrust-2 is expected in 2025. 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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