Nkarta Presents Initial Safety Data for NKX019 in 40 Patients Across Five Autoimmune Diseases at ACR Convergence 2026
Key Highlights
- ➤NKX019 safety data covered 40 patients across five autoimmune diseases.
- ➤No CRS, ICANS, IEC-HS, GvHD, deaths, or adverse-event treatment discontinuations reported.
- ➤Grade 3+ adverse events occurred in 14 patients, mainly hematologic and linked to lymphodepletion.
- ➤Five patients had NKX019-related infusion reactions; all resolved within 24-48 hours without tocilizumab.
- ➤No adverse-event frequency increase observed across 1 billion, 2 billion, and 4 billion cell doses.
Expert Statements
Paul J. Hastings, Chief Executive Officer of Nkarta
“The absence of CRS, ICANS, IEC-HS and GvHD across 40 patients and five autoimmune diseases reinforces our belief that CAR NK cells could offer a differentiated approach to autoimmune cell therapy.”
Paul J. Hastings, Chief Executive Officer of Nkarta
“Unlike CAR T cells, which can undergo rapid and substantial expansion in the body, NKX019 is designed to deliver targeted B-cell depletion with limited in vivo expansion and more predictable cellular exposure.”
Paul J. Hastings, Chief Executive Officer of Nkarta
“These fundamental biological differences may allow us to achieve the therapeutic benefits of CD19-directed cell therapy without the toxicities associated with autologous T cell-based modalities.”
Guillermo J. Valenzuela, Integral Rheumatology and Immunology Specialists
“For patients living with refractory autoimmune diseases, the burden is progressive disability, pain and the uncertainty of whether the next treatment will work after so many others have failed.”
Guillermo J. Valenzuela, Integral Rheumatology and Immunology Specialists
“Cell therapy offers new hope, but access is currently constrained by where patients live and whether they can access a highly specialized treatment center.”
Guillermo J. Valenzuela, Integral Rheumatology and Immunology Specialists
“If we can deliver the therapeutic potential of CD19-directed cell therapy with a manageable safety profile, patients could receive these treatments in their own communities from rheumatologists who know them.”
Guillermo J. Valenzuela, Integral Rheumatology and Immunology Specialists
“That would represent a sea change in autoimmune care.”
* No cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), or graft-versus-host disease (GvHD) across 40 patients treated across five indications in the Ntrust program.
* No deaths and no treatment discontinuations due to adverse events. * Grade 3 or higher treatment-emergent adverse events were primarily hematologic and attributed to lymphodepletion.
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