Add-on cell therapy may ease Sjögren’s symptoms, boost saliva

Add-on treatment with Artiva Biotherapeutics’ experimental cell therapy AlloNK (AB-101) was associated with improvements in symptoms and increased saliva flow at six months in a small group of adults with difficult-to-treat Sjögren’s disease in a basket clinical trial.

However, the global Phase 2a study (NCT06991114) is a single-arm trial with no control group, so larger, appropriately controlled trials are needed to confirm the benefits. The basket trial is testing AlloNK in combination with rituximab, a B-cell-depleting therapy, in adults with Sjögren’s or other autoimmune diseases driven by B-cells, the immune cells that produce antibodies, including self-reactive ones.

“We believe these results support continued evaluation of AlloNK plus rituximab as an outpatient-administered deep B-cell-depleting regimen for patients with B-cell-driven autoimmune diseases,” Fred Aslan, MD, CEO of Artiva, said in a company press release. “We look forward to following these patients to assess the durability of their responses.”

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Sept. 30, 2026 News by Marisa Horak, MS

Experimental therapy rapidly lowers disease activity in Sjögren’s trial

Cell therapy designed to deepen B-cell depletion

The findings were shared by Guillermo J. Valenzuela, MD, medical director of Integral Rheumatology and Immunology Specialists in Florida, during an oral presentation at this year’s International Symposium on Sjögren’s Disease in Paris. The talk was titled “AB-101, an Outpatient-Administered Allogeneic NK Cell Therapy, Combined with Rituximab Generates Robust Efficacy Responses in 11 Patients with Sjögren Disease.”

Sjögren’s is an autoimmune disease in which the immune system mistakenly attacks healthy tissues, especially the glands that produce saliva and tears. This can result in symptoms such as dry mouth and eyes, fatigue, and joint pain.

AlloNK uses natural killer (NK) immune cells from healthy donors to boost the destruction of B-cells targeted by antibody-based therapies such as rituximab. Rituximab, marketed as Rituxan or Mabthera and also available as biosimilars, binds to CD20, a protein on the surface of B-cells.

This binding marks the cells for immune-mediated destruction. The NK cells in AlloNK are designed to recognize and kill these antibody-bound B-cells, helping drive deeper B-cell depletion. This deeper depletion is intended to target the B-cell activity involved in Sjögren’s and other B-cell-driven autoimmune diseases. In Sjögren’s, the treatment has the potential to provide clinical benefit, including easing symptoms of Sjögren’s.

As part of the ongoing trial, participants first receive cyclophosphamide and fludarabine as a conditioning regimen to suppress the immune system and help reduce the chance that the delivered NK cells will be rejected.

This is followed by three weekly doses of AlloNK and two doses of rituximab given two weeks apart in an outpatient setting. Both AlloNK and rituximab are given as infusions into a vein.

Disease activity, symptoms improve at 6 months

The newly reported results included 11 people with Sjögren’s who had been followed for at least six months after treatment. All were women with hard-to-treat, highly active disease who had been living with Sjögren’s for an average of 12.2 years.

After six months, the mean Clinical European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index (ClinESSDAI) score, which measures disease activity throughout the body, dropped (improved) by 6.9 points.

The mean EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score, which reflects a patient’s perception of dryness, fatigue, and pain, was also reduced (improved) by 3.5 points. Both score changes exceeded the thresholds for minimal clinically important improvement.

Looking at the individual symptoms measured by the ESSPRI, 82% of participants had at least a one-point improvement in dryness, 73% in pain, and 55% in fatigue. On a separate measure of fatigue, the Functional Assessment of Chronic Illness Therapy — Fatigue, the average score improved by 13 points.

“Responses beyond the initial conditioning period were seen as early as Week 8 and deepened over time,” researchers wrote in the abstract submitted for the oral presentation. “These responses were markedly higher than what have been reported with rituximab alone in [Sjögren’s] clinical trials.”

Salivary flow increases in 8 patients

Eight participants who produced low amounts of saliva at the trial’s start had available measurements six months after treatment. Their mean stimulated salivary flow, or saliva production measured after it is triggered by a stimulus such as chewing, increased from 0.4 to 1.1 mL per minute, “exceeding the threshold for normal salivation of greater than 1.0 mL/min,” the release stated.

The company also reported safety results from 73 participants in the broader trial, including those with rheumatoid arthritis, systemic sclerosis, and inflammatory myositis. The most commonly reported treatment-emergent adverse events were nausea (40%), headache (27%), and low numbers of immune cells called lymphocytes (25%).

Eight participants (11%) experienced serious adverse events, including two serious infections that were reported as unrelated to AlloNK.

There were no reports of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome, two serious complications associated with certain cell therapies. There also were no cases of hypogammaglobulinemia, or abnormally low levels of antibodies.

“The overall safety profile was consistent with findings expected with the conditioning regimen and rituximab,” the researchers wrote.

Across several autoimmune studies, B-cell depletion was seen by Day 13 in all 51 participants. Among 13 participants whose B-cells later returned, a greater proportion were naïve or transitional B-cells. The presentation described this pattern as a “B-cell reset.”

“These results support the potential for [AlloNK] plus rituximab to drive deep B-cell depletion and to generate robust clinical responses in [Sjögren’s],” the researchers wrote.