Nkarta Inc（NKTX）のニュースとイベントNKTXNkarta Inc

Nkarta CEO: Expanding Access to NKX019 at 4 Billion Cell Dose

"Expanding access to NKX019 in the communities where autoimmune patients already receive care is central to how we're advancing this program," said Paul J. Hastings, Chief Executive Officer of Nkarta. "This quarter, we continued to enroll patients across all indications in Ntrust-1 and Ntrust-2 at the 4 billion cell dose level. Following our recent agreement with the FDA on outpatient dosing, we have begun administrating NKX019 through our expanding network of community-based sites, with re-dosing available, if needed, to patients in both trials. We look forward to presenting our initial clinical dataset from Ntrust-1 and Ntrust-2 at a medical conference in 2026."

Nkarta Reaches Agreement with FDA to Expand Patient Access

"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 Reaches Agreement with FDA on Ntrust Clinical Trials

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.