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Biotechnology: Pharmaceutical Preparations
Clinical TrialApr 15, 2026, 04:03 PM

Nkarta Reaches FDA Agreement on Ntrust Trial Changes

AI Summary

Nkarta, Inc. announced an agreement with the FDA on key changes to its Ntrust-1 and Ntrust-2 clinical trials for NKX019, an investigational CAR-NK cell therapy for autoimmune diseases. The amendments will enable outpatient administration, significantly reducing patient burden by cutting monitoring time from 24 hours to 2 hours, and expanding access to community research centers. Additionally, the company gained flexibility to re-dose patients in both studies and will add a rheumatoid arthritis cohort to Ntrust-2, broadening the trial's scope.

Key Highlights

  • FDA agreed to protocol amendments for Ntrust-1 and Ntrust-2 clinical trials.
  • Outpatient administration of NKX019 enabled, reducing patient monitoring from 24 hours to 2 hours.
  • Option to re-dose patients granted in both Ntrust-1 and Ntrust-2 studies.
  • Rheumatoid arthritis cohort to be added to the Ntrust-2 study.
  • Dosing continues at 4 billion cell dose level (12 billion cells in 3-dose cycle).