Nkarta gets FDA approval for outpatient dosing of autoimmune therapy

Nkarta Inc. (NASDAQ: NKTX) announced it reached agreement with the U.S. Food and Drug Administration on protocol changes for its ongoing Ntrust-1 and Ntrust-2 clinical trials that will enable outpatient administration of its investigational therapy NKX019.

The agreement reduces required patient monitoring from 24 hours to 2 hours and eliminates the need for overnight hospital stays. The changes will allow community rheumatology centers to administer the CAR-NK cell therapy, according to the company's statement.

The FDA also approved the option to re-dose patients in both studies if needed to optimize treatment responses. A rheumatoid arthritis cohort will be added to the Ntrust-2 trial once final protocol amendments receive institutional review board approval.

"Reaching agreement with the FDA on outpatient dosing will reduce patient burden and expand access," said Paul J. Hastings, Nkarta's chief executive officer.

The Ntrust trials are testing NKX019 in patients with autoimmune diseases including lupus nephritis, primary membranous nephropathy, systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis. Patients receive a three-dose cycle of NKX019 on days 0, 3, and 7 following lymphodepletion treatment.

NKX019 is an allogeneic, cryopreserved immunotherapy that uses natural killer cells derived from healthy adult donors. The therapy is engineered with a CD19-directed chimeric antigen receptor and a membrane-bound form of interleukin-15.

The company continues dosing at the 4 billion cell dose level, with 12 billion cells administered in the complete three-dose cycle. Initial data from the trials is expected to be presented at a medical meeting this year.

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