The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Adicet Bio’s ADI-001 for refractory systemic lupus erythematosus (SLE) with extrarenal involvement (when a disease affects organs outside of the kidneys, like the heart, liver or brain).
ADI-001 is an investigational allogeneic gamma delta CAR-T cell therapy that targets B cells. Adicet Bio is currently testing ADI-001 across six autoimmune indications. The phase 1 study has four separate arms, investigating 1) people with lupus nephritis (LN) and 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. 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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