SAN DIEGO, California — September 8, 2026
Artiva Biotherapeutics, Inc. announced planned clinical data disclosures and development milestones for AlloNK® (AB-101) through the remainder of 2026, including initiation of an FDA-aligned Phase 3 registrational trial in refractory rheumatoid arthritis (RA). The company expects to disclose updated data from at least 20 patients with refractory RA treated with AlloNK plus rituximab in its ongoing Phase 2a basket trial, with each patient having at least six months of follow-up. At least 10 of these patients are expected to meet key eligibility criteria for the planned Phase 3 study. Artiva also expects updated clinical data from at least 10 patients with Sjögren disease and five patients with systemic sclerosis, providing additional evidence across B-cell-driven autoimmune diseases. The company said these milestones represent a significant step in advancing AlloNK toward late-stage clinical development.
AlloNK Targets Deep B-Cell Depletion
AlloNK is an allogeneic, off-the-shelf, non-genetically modified and cryopreserved natural killer (NK) cell therapy candidate designed to enhance antibody-dependent cellular cytotoxicity and drive deep B-cell depletion. The therapy is being evaluated in combination with rituximab and other anti-CD20 antibodies, with the objective of improving the depth of B-cell depletion in autoimmune diseases. Artiva previously reported encouraging ACR50 response rates in refractory RA patients receiving AlloNK plus rituximab, while reporting no cases of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome or treatment discontinuation due to adverse events as of April 3, 2026. The company believes the combination of an off-the-shelf cell therapy and antibody treatment could potentially support a scalable and outpatient-compatible approach to deep B-cell depletion in community rheumatology settings.
Phase 3 Trial to Enroll Approximately 150 RA Patients
Artiva plans to initiate a randomized, controlled Phase 3 trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 patients with refractory RA. The study will enroll patients who have experienced inadequate responses to at least two distinct classes of biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). The primary efficacy endpoint will be an ACR50 response at six months. Artiva said it has alignment with the FDA on conducting a single registrational trial and will evaluate whether AlloNK plus rituximab can achieve an ACR50 response rate above 50%, compared with an expected response of approximately 20% for rituximab alone based on published literature and real-world evidence. Further updates on clinical-site activation and enrollment initiation are expected during the second half of 2026, with topline results targeted by the end of 2028.
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Artiva Expands AlloNK Autoimmune Development
The planned Phase 3 program strengthens Artiva’s broader strategy to develop AlloNK across multiple B-cell-driven autoimmune diseases. In addition to refractory RA, the company is evaluating AlloNK in Sjögren disease, systemic sclerosis and myositis, with updated clinical data expected from selected patients during the second half of 2026. Artiva believes the platform’s off-the-shelf manufacturing model and compatibility with antibody-based treatment could support broader application across autoimmune indications where deep B-cell depletion may provide therapeutic benefit. The company also holds FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its lead program and expects its cash runway to extend into 2029, beyond the planned Phase 3 topline readout. With Phase 3 development beginning in refractory RA and additional clinical data expected across autoimmune diseases, Artiva Biotherapeutics is positioning AlloNK as a potentially scalable cell-therapy platform for deep B-cell depletion.
Source: Artiva Biotherapeutics press release
