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Nkarta Announces IND Clearance of Investigator-Sponsored Trial in Myasthenia Gravis and Opening of Enrollment for Ntrust-2
Ntrust-2 open to enroll patients with systemic sclerosis, myositis and ANCA-associated vasculitis across three parallel cohorts Investigator-Sponsored Trial
About this update from Nkarta, Inc.
[{"type":"text","content":"Ntrust-2 open to enroll patients with systemic sclerosis, myositis and ANCA-associated vasculitis across three parallel cohorts Investigator-Sponsored Trial (IST) expands the development of NKX019 to neuromuscular autoimmune disease myasthenia gravis Patient dosing initiated and enrollment open in Ntrust-1 and IST of NKX019 in systemic lupus erythematosus Clinical data from Ntrust-1 and Ntrust-2 planned for 2025 SOUTH SAN FRANCISCO, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced the opening of Ntrust-2 to enrollment and the IND clearance for an investigator-sponsored trial (IST) that will evaluate NKX019, Nkarta’s allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy, in patients with myasthenia gravis (MG). Ntrust-2, a multi-center clinical trial, will evaluate NKX019 across three parallel cohorts, including patients with systemic sclerosis (SSc, scleroderma), idiopathic inflammatory myopathy (IIM, myositis) and ANCA-associated vasculitis (AAV). The IST will be led by researchers at the University of California, Irvine and the University of Kansas Medical Center. NKX019 is an allogeneic, off-the-shelf, chimeric antigen receptor (CAR) NK-cell therapy candidate engineered to deplete CD19-positive cells in B-cell mediated disease. The approach leverages the potential advantages of NK cell therapy, including rapid B-cell killing without the need for cell expansion, a lower risk of toxicities associated with rapid cell expansion, fludarabine-free lymphodepletion to reduce toxicity, and the added utility of on-demand dosing, including the opportunity for repeated dosing as needed. “The expansion to these four autoimmune indications, in addition to continued execution across our existing clinical trials for lupus nephritis and systemic lupus erythematosus, speaks to the promise of our investigational NK cell therapy, NKX019, to provide a safe and accessible treatment option for people living with autoimmune disease,” said Paul J. Hastings, CEO of Nkarta. Ntrust-2 is a multi-center, open label, dose escalation clinical trial that builds on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy. The trial will enroll patients with...