Artiva to Present AlloNK Data Showing CAR T-Like B-Cell Depletion in Rheumatologic Diseases at ACR 2026

Artiva Biotherapeutics will present data from its AlloNK (AB-101) program in rheumatologic diseases at the American College of Rheumatology (ACR) Convergence 2026, the company announced on Oct. 2, 2026.¹ The data include an oral presentation reporting efficacy responses comparable with autologous CAR T-cell therapy in 34 patients.¹ AlloNK is an allogeneic, off-the-shelf, non-genetically modified natural killer (NK) cell therapy. It's given with rituximab, an anti-CD20 monoclonal antibody, to deplete B cells in patients with refractory autoimmune disease.¹

How does AlloNK work?

AlloNK consists of cryopreserved NK cells designed to enhance antibody-dependent cellular cytotoxicity when administered with therapeutic antibodies such as rituximab.¹ The cells aren't genetically modified and are manufactured as an off-the-shelf product, and Artiva positions the outpatient regimen as scalable and suitable for community rheumatology settings.¹ In the planned phase 3 regimen, patients receive low-dose cyclophosphamide and fludarabine conditioning on Days 1 through 3. They then receive 2 doses of 4 billion AlloNK cells, on Days 6 and 20, along with rituximab.²

What will Artiva present at ACR 2026?

The oral presentation, scheduled for Nov. 9, will report efficacy in 34 patients with rheumatologic diseases. A poster on Nov. 10 will describe safety and B-cell depletion in a cohort of 60 patients.¹ The presented data include at least 20 patients with refractory rheumatoid arthritis (RA), 11 with Sjögren disease, and at least 5 with systemic sclerosis, all with at least 6 months of follow-up.¹ A third poster presents a US registry analysis of unmet need and clinical response rates in patients with RA who have failed 2 or more classes of biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs).¹ Artiva will also host a webcast on Nov. 9, 2026. It will include an analysis of at least 10 patients with refractory RA who meet the eligibility criteria for the company's planned phase 3 trial.¹

The Oct. 2 announcement doesn't include new efficacy figures. In data Artiva reported in May 2026, all 51 treated patients achieved complete B-cell depletion by Day 13.² In the Phase 2a study, 5 of 7 patients with RA who reached 6 months of follow-up achieved an ACR50 response.² No cases of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome were reported, and the rate of grade 3 or higher infection was 2%.²

"A new chapter begins for Artiva as we advance the first deep B-cell depleting therapy into a registrational trial in RA," said Fred Aslan, MD, president and chief executive officer of Artiva, in the May 2026 announcement.²

Where does AlloNK fit among cell therapies for autoimmune disease?

In RA, the immune system attacks the body's own tissues, primarily damaging the joints of the hands, wrists, and knees.³ Developers of autologous and allogeneic CAR T-cell therapies are also pursuing deep B-cell depletion as a way to reset the immune system in autoimmune disease. Artiva's emphasis on outpatient administration in community rheumatology settings speaks to a broader access challenge for cell therapies. In a video interview with BioPharm International®, Anna Catalanotto, director of advanced therapy commercial strategy at Cardinal Health, described where these therapies are delivered today. "Historically, while the majority of cell and gene therapies are being administered and treated in large health care systems, large academic centers, there are a lot of challenges," Catalanotto said.

What happens next?

Artiva plans to start a single randomized Phase 3 registrational trial of AlloNK plus rituximab versus rituximab alone in about 150 patients with refractory RA.² Patients will have had an inadequate response to at least 2 b/tsDMARD classes.² The primary end point is ACR50 response at 6 months. Artiva expects to start the trial in the second half of 2026 and to report primary efficacy data in the second half of 2028.²

References

1. Artiva Biotherapeutics. Artiva Biotherapeutics Announces Multiple AlloNK® Data Presentations at the American College of Rheumatology (ACR) Convergence 2026. Press release. Published October 2, 2026. Accessed October 2, 2026.
2. Artiva Biotherapeutics. Artiva Announces Positive Initial Clinical Data with AlloNK® Across Multiple Autoimmune Diseases and FDA Alignment to Initiate Phase 3 Registrational Trial in Rheumatoid Arthritis in 2026. Press release. Published May 8, 2026. Accessed October 2, 2026.
3. Centers for Disease Control and Prevention. Rheumatoid Arthritis (RA). Accessed October 2026.