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.
