First Person Dosed with Investigational Therapy, ADI-001, for Treatment of Lupus Nephritis

Adicet Bio announced the first person with lupus nephritis (LN) has been dosed with ADI-001, an investigational allogeneic gamma delta CAR T cell therapy that targets B cells. The phase 1 study of ADI-001 in autoimmune diseases is currently underway with preliminary clinical data expected in 2025. 

The phase 1 study has four separate arms, investigating 1) people with LN and systemic lupus erythematosus (SLE) in one group, 2) people with systemic sclerosis, also known as scleroderma, 3) people with idiopathic inflammatory myopathy (IIM, an autoimmune disease that causes muscle weakness, inflammation and pain) and stiff person syndrome (SPS, an autoimmune neurological disorder that causes muscle spasms and stiffness), and 4) people with anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis. Each enrolled person will receive a single dose of ADI-001 and have response and safety assessments conducted on Day 28 and during the follow up period at 3, 6, 9, 12, 18, and 24 months. Study objectives include evaluating the safety and tolerability of ADI-001, as well as measuring cellular kinetics, pharmacodynamics (biochemical and physiologic effects of drugs on the body), changes in autoantibody titers, and appropriate activity scores for each of the disease states. 

Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about medications used to treat lupus.

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