Nkarta Targets ACR 2026 Data Reveal as Outpatient CAR NK Trials Advance

Key Points

• Nkarta expects to present initial autoimmune-disease data at the ACR 2026 meeting, with presentations covering myositis, scleroderma and safety across its CAR NK program. The data will include several patients with roughly three months of follow-up and may provide insight into dose response, durability and retreatment.
• FDA-agreed protocol changes now support outpatient administration of Nkarta’s off-the-shelf CAR NK therapy, reducing observation to two hours and removing prior requirements for prolonged monitoring and proximity to treatment centers. The company says community sites and patient-support services have improved trial access and enrollment.
• Nkarta plans to narrow its focus to the most promising autoimmune indications and is targeting a potential registrational study before the end of 2027. Management said longer-term efficacy, safety and durability data will be critical to proving CAR NK therapy can match CAR T benefits with fewer treatment burdens and immune-related toxicities.

Nkarta NASDAQ: NKTX said it expects to present initial clinical data from its autoimmune disease programs at the American College of Rheumatology’s 2026 Convergence meeting in November, including presentations in myositis, scleroderma and program-wide safety.

The company is developing an allogeneic, off-the-shelf CD19-targeted CAR natural killer, or CAR NK, cell therapy for autoimmune diseases. President Nadir Mahmood said Nkarta’s approach is intended to pursue therapeutic benefits seen with autologous CAR T therapies while offering outpatient administration, on-demand availability and the potential for broader patient access.

Nkarta is studying the treatment across two company-sponsored investigational new drug applications. Its Ntrust-1 study is focused on lupus nephritis, while Ntrust-2 is a basket study including scleroderma, myositis, vasculitis and rheumatoid arthritis.

Protocol Changes Support Outpatient Dosing

Chief Executive Officer Paul Hastings said protocol amendments agreed with the Food and Drug Administration have removed several earlier restrictions that had been imposed as Nkarta moved from oncology into autoimmune disease.

According to Hastings, patients previously faced patient-by-patient dosing staggers, a 24-hour observation period following cell administration and a requirement to remain within 60 miles of the treatment center for 30 days. Under the amended protocol, he said patients can receive off-the-shelf cells, be observed for two hours and return home.

“All outpatient administration of these cells, no hospitalization time,” Hastings said, adding that the company has also condensed its dosing schedule and is evaluating a potentially more compressed regimen with regulators.

The company has added community-based treatment centers and provides patient-support services that may include travel, daycare and reimbursement for missed work, Hastings said. He said these measures have improved enrollment and may expand trial access beyond academic medical centers.

ACR Data Plan Centers on Myositis, Scleroderma and Safety

Mahmood said Nkarta will have three ACR presentations: an oral presentation on myositis, a poster on scleroderma and a separate oral presentation focused on safety across the program. The safety presentation will cover all indications and dose levels in the autoimmune studies.

The myositis and scleroderma presentations are expected to include “about a handful or more” patients with at least roughly three months of follow-up, Mahmood said. Nkarta has escalated from 1 billion cells to 2 billion cells and then 4 billion cells per dose, and management said it believes the current dose level can provide data relevant to the program’s future direction.

Hastings said investors should look for evidence of a dose-response relationship, durability among responders treated at lower doses and early evidence regarding retreatment. He said the company will also hold a company-sponsored event at ACR to discuss the data in greater detail.

Nkarta plans to use clinical outcomes alongside pharmacokinetic and pharmacodynamic analyses, including B-cell depletion. Hastings said the company is conducting lymph-node biopsies to evaluate B-cell depletion beyond blood-based measurements and is assessing whether depletion correlates with durable clinical responses.

The company is also conducting patient-reported outcome work alongside its clinical studies. Hastings said the effort is intended to capture how symptoms affect patients in their daily lives, in addition to established disease-activity measures used in myositis, scleroderma and other autoimmune conditions.

Focus on Selected Indications and Registrational Path

Management said Nkarta intends to narrow its focus from a broader set of autoimmune indications to a more specific group after reviewing available data. Hastings said the company expects to prioritize indications with meaningful clinical data, durable responses, favorable enrollment dynamics and less competitive trial environments.

While Nkarta plans to continue collecting data in Ntrust-1 and Ntrust-2, it may revisit investigator-sponsored studies and other indications over time. The company is also considering whether higher doses or other regimen modifications could further deepen responses while preserving the safety profile.

For enrolled patients, Nkarta does not allow background immunomodulatory therapies other than permitted low-dose steroids, according to Hastings and Mahmood. Hastings said steroids may help limit disease flares as patients discontinue prior treatments before receiving the cell therapy.

Hastings said the company aims to match the efficacy and durability reported for CAR T approaches while offering a better safety profile. He said Nkarta sees the potential absence of rapid in-patient expansion and related immune toxicities as a possible differentiator for CAR NK cells, though he emphasized that durability and safety data will be important in demonstrating that potential.

On regulatory development, Hastings said the FDA has been receptive to single-arm cell-therapy studies when programs demonstrate safety and efficacy through dose escalation. He expressed high confidence that Nkarta could initiate a registrational effort before the end of 2027, while noting that the company plans to continue generating longer-term durability data as its studies advance.

About Nkarta (NASDAQ:NKTX)

Nkarta, Inc is a clinical-stage biotechnology company developing engineered natural killer (NK) cell therapies for the treatment of cancer. The company's approach is designed to use allogeneic, or donor-derived, immune cells that can be manufactured for use across multiple patients, with the goal of providing an off-the-shelf alternative to individualized cell therapies.

Nkarta's product candidates include NKX101, an engineered CAR NK cell therapy designed to recognize NKG2D ligands expressed on certain cancer cells, and NKX019, a CD19-targeted CAR NK cell therapy being developed for B-cell malignancies.

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