GlobeNewswire·Apr 15, 2026, 4:01 PM ET

Nkarta Announces FDA Agreement on Outpatient Dosing of NKX019 in Autoimmune Disease, Expanding Access to Community Rheumatology Centers

Nkarta, Inc. reached an FDA agreement to amend the Ntrust-1 and Ntrust-2 clinical trial protocols for its investigational therapy NKX019.
Protocol changes enable outpatient administration of NKX019 at community research centers & rheumatology sites to reduce patient burden.
Patient monitoring requirements are reduced from 24 hours to 2 hours following dosing.
An option to redose patients has been granted for both the Ntrust-1 and Ntrust-2 studies to optimize treatment responses.
A rheumatoid arthritis cohort will be added to the Ntrust-2 trial following final IRB review.
Geographic monitoring restrictions have been removed to further facilitate patient access.
Dosing continues at a 4 billion cell dose level, utilizing a 12 billion cell total across a 3-dose cycle administered on Days 0, 3, & 7.
Initial clinical data from these updated trials is expected to be presented at a medical meeting in 2026.
NKX019 is an allogeneic, off-the-shelf CAR-NK cell therapy targeting CD19 to eliminate pathogenic B cells in autoimmune diseases.
The trial expansion builds on current indications including lupus nephritis, primary membranous nephropathy, systemic sclerosis, idiopathic inflammatory myopathy, & ANCA-associated vasculitis.