Nkarta Initiates Clinical Trial of NKX019 in Lupus Nephritis with First Patient in Screening and Announces Pipeline Expansion to Additional Autoimmune Indications

Core Insights - Nkarta, Inc. has initiated Ntrust-1, the first U.S.-based clinical trial of NKX019 for lupus nephritis, with patient screening currently underway [21] - The company has received FDA clearance for its second IND application for NKX019, allowing the initiation of Ntrust-2 for systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis [21][11] - NKX019 is an engineered allogeneic CAR NK-cell therapy designed to target CD19-positive cells, offering potential advantages such as reduced toxicity and on-demand dosing [1][17] Company Developments - Ntrust-1 and Ntrust-2 are multi-center, open-label, dose escalation clinical trials aimed at assessing the safety and efficacy of NKX019 in autoimmune diseases [12] - The trials will evaluate NKX019's ability to induce long-term remissions by eliminating pathogenic B cells, with each trial initially enrolling up to 12 patients [4][12] - Nkarta aims to improve the accessibility and safety of cell therapy, particularly for underserved populations with lupus and other autoimmune diseases [11] Industry Context - Systemic lupus erythematosus (SLE) affects approximately 200,000 patients in the U.S., with about 40% developing lupus nephritis, a severe manifestation of the disease [23] - Systemic sclerosis (SSc) has around 100,000 patients in the U.S., with no available treatments to halt or reverse the disease process [6] - Idiopathic inflammatory myopathy (IIM) affects an estimated 50,000 people in the U.S., with many patients experiencing refractory disease despite existing therapies [7]