GlobeNewswire·Nov 9, 2026, 7:00 AM ET

Nkarta Announces Initial Clinical Data for NKX019 in Myositis and Systemic Sclerosis at ACR Convergence

NKTX

Nkarta announced positive initial clinical data for its investigational allogeneic CAR NK cell therapy, NKX019, from the Ntrust program presented at ACR Convergence 2026.
In myositis patients treated at a 4 billion-cell dose, 83% (5/6) achieved moderate or major responses measured by the Total Improvement Score (TIS) with at least three months of follow-up.
In systemic sclerosis patients treated at a 4 billion-cell dose, 86% (6/7) achieved an rCRISS-25 response or greater, while 71% (5/7) achieved an rCRISS-50 response or greater.
Systemic sclerosis patients treated at the 4 billion-cell dose showed rapid skin responses with a median 15-point reduction in modified Rodnan skin score (mRSS) at Day 90, where 71% achieved at least a 50% reduction from baseline.
No immune effector cell-associated toxicities, including cytokine release syndrome (CRS), ICANS, IEC-HS, or graft-versus-host disease (GvHD), were observed among 40 patients treated across five indications.
Treatment was well-tolerated with no deaths, no treatment discontinuations due to adverse events, and no cases of leukoencephalopathy reported.
Deep peripheral CD19+ B-cell depletion was observed at the 4 billion-cell dose, with a pattern consistent with a B-cell immune reset in patients with low to moderate naïve B cells at baseline.
Patients received three doses of NKX019 on Days 0, 3, and 7 following lymphodepleting preconditioning, totaling 12 billion cells in the initial dosing schedule.
Nkarta amended Ntrust protocols to compress dosing to Days 0, 2, and 4 based on T-cell recovery data, with plans to evaluate a 6 billion-cell dose.
The company anticipates FDA interactions to discuss registrational pathways for myositis and systemic sclerosis, with plans to report additional data in the first half of 2027.
An investor webcast regarding these findings was scheduled for November 9, 2026, at 8 a.m. ET.