Nkarta initiates trial of NKX019 in lupus nephritis

Nkarta announced the initiation of Ntrust-1, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening. The company also announced the clearance by the FDA of its second Investigational New Drug application for NKX019 in autoimmune disease. With this new IND, Nkarta plans to initiate Ntrust-2, an open-label, multi-center clinical trial of NKX019 for the treatment of systemic sclerosis, idiopathic inflammatory myopathy and ANCA-associated vasculitis. NKX019 is engineered to exert its biologic activity without the need for antibodies or exogenous cytokines. Ntrust-1 and Ntrust-2 are multi-center, open label, dose escalation clinical trials that build on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its ability to enable long-term remissions via a “reset” of the immune system through the elimination of pathogenic B cells. Clinical data from Ntrust-1 and Ntrust-2 is planned for 2025