Clinical TrialNov 9, 2026, 09:26 AM
Nkarta: NKX019 Shows Positive Initial Data in Myositis, Scleroderma
AI Summary
Nkarta, Inc. announced initial clinical data from its Ntrust-2 trial evaluating NKX019, a CAR NK cell therapy, in patients with myositis and systemic sclerosis. The data presented at ACR Convergence 2026 showed promising efficacy and a favorable safety profile. In myositis, 83% of patients achieved moderate or major responses, and in systemic sclerosis, 86% achieved a significant response. The company is also adjusting its development plan, including compressed dosing schedules and higher dose evaluations, and plans to engage with the FDA regarding registrational pathways.
Key Highlights
- In myositis, 83% of patients (6/6) at 4B cells/dose with >=3 months follow-up achieved moderate/major TIS responses.
- In systemic sclerosis, 86% of patients (6/7) at 4B cells/dose with >=3 months follow-up achieved rCRISS-25 or greater.
- Systemic sclerosis patients at 4B cells/dose saw a median mRSS reduction of 15 points by Day 90 (71% achieved >=50% reduction).
- No deaths, treatment discontinuations due to AEs, CRS, ICANS, IEC-HS, or GvHD observed in 40 patients across Ntrust trials.
- Nkarta plans to compress dosing to Days 0, 2, and 4, and evaluate 6 billion cells per dose.
- Company anticipates FDA interactions to discuss potential registrational pathways in myositis and systemic sclerosis.
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