NKTX News & Events

"Putting patients first and providing access to care in a familiar setting close to home matters" said Paul Hastings, CEO of Nkarta. "In early April, we reached agreement with the FDA to amend our protocol to allow outpatient dosing in community settings as well as the option to re-dose patients if needed, the removal of overnight monitoring requirements, and the expansion of the Ntrust-2 study to include patients with rheumatoid arthritis. IRB approval of our protocol amendments has been secured across multiple sites, with additional approvals underway. These advancements will enable us to expand patient access beyond urban hubs and major academic centers by engaging community research centers and local rheumatology practices in the neighborhoods where most patients live. We look forward to providing our initial dataset in 2026."

Nkarta announced that it has reached agreement with the FDA on key changes to the ongoing Ntrust-1 and Ntrust-2 clinical trials. The protocol amendments are designed to alleviate the need for overnight stays and reduce the overall burden on patients, enabling outpatient administration of NKX019 - an investigational CAR-NK cell therapy - by community research centers and community rheumatologists. Following submission of the final amendments to FDA and IRB approvals: outpatient administration will be enabled for both Ntrust-1 and Ntrust-2. Option to re-dose will be allowed, if needed, in Ntrust-1 and Ntrust-2. Rheumatoid arthritis cohort will be added as an indication in Ntrust-2. No geographic monitoring requirements remain.