Nkarta (NKTX) is moving its CD19-targeted CAR natural killer cell therapy away from academic medical centers toward community-based sites, trimming dosing to three infusion days and shortening observation to roughly two hours — all aimed at making the off-the-shelf treatment cheaper and accessible to a broader autoimmune patient population.
The changes were outlined Wednesday at the Stifel 2026 Virtual Immunology and Inflammation Forum by CEO Paul Hastings and President Nadir Mahmood. Nkarta holds two company-sponsored INDs: Ntrust-1 targets lupus nephritis, while Ntrust-2 is a basket study covering scleroderma, myositis, vasculitis and rheumatoid arthritis. Investigator-sponsored trials are also enrolling in myasthenia gravis and lupus with or without nephritis.
Hastings said the company plans to narrow its indication portfolio from six across the two INDs down to a smaller group by end of 2024, with registrational trials expected before the end of 2027. Data from the expanded program will be presented at the American College of Rheumatology Convergence 2026 in November.
Dosing has been stepped from 1 billion to 2 billion cells, and the current standard is 4 billion cells per dose using a flu/cyclophosphamide lymphodepletion regimen. The schedule has been compressed to days 0, 3 and 7, with further condensation under discussion with the FDA.
Following FDA consultations, Nkarta removed previous requirements for a 24-hour observation stay and a 60-mile travel limit for 30 days post-dosing. Patients now remain for about two hours before returning home. The company added travel assistance, daycare reimbursement and work-loss compensation for patients who request them.
"NK cells don't expand in humans as much as T cells do. The dose you give is the dose you get," Hastings said. He argued this limits the hyperimmune responses associated with CAR T. "Where NK cells are going to come out is you're not going to see any of the hyperimmune syndrome because we don't have that rapid expansion in the patient and the release of all those cytokines and the ICANS and the cytokine release syndrome that comes with it." The goal, he said, is to "match their efficacy and give a better safety profile."
Hastings noted the FDA required Nkarta to rebuild its safety database from scratch when moving from oncology into autoimmune populations. "Autoimmune patients are going to react differently to chronic therapies than to an oncology patient with a therapeutic," he said.
Mahmood said the company expects to show data from a "handful or more" of patients with at least three months of follow-up at clinically meaningful doses, displaying dose-response patterns, durability and retreatment effects. Community-based investigators, including Dr. Valenzuela, the company's highest enroller, and Dr. Dinesh Khanna, a scleroderma expert, are expanding access beyond the academic centers that currently reach roughly 5% of eligible patients.
Nkarta shares closed at $2.83 on September 18. The current ratio stands at 7.98. Analyst price targets range from $9 to $14. The company is scheduled to report earnings on November 11, 2026.
Lilly was mentioned during the discussion as a peer in the autoimmune space.
