San Diego‑based Artiva Biotherapeutics (NASDAQ: ARTV) announced on Tuesday that it has begun a registrational Phase 3 trial of its AlloNK therapy in combination with rituximab for patients with refractory rheumatoid arthritis.
The double‑blind, randomized study will enroll roughly 150 participants who have failed at least two distinct classes of biologic or targeted synthetic disease‑modifying anti‑rheumatic drugs. Patients will be assigned to receive AlloNK plus rituximab or rituximab alone. The primary efficacy endpoint is the proportion of patients achieving an ACR50 response at six months. Artiva expects the combination to exceed a 50% response rate, compared with an anticipated 20% rate for rituximab monotherapy based on published data.
AlloNK is an allogeneic, off‑the‑shelf, cryopreserved natural‑killer cell product that enhances antibody‑dependent cellular cytotoxicity. The therapy carries FDA Regenerative Medicine Advanced Therapy (RMAT) designation, and the company has secured alignment with the agency to conduct a single registrational trial.
Topline results are slated for the end of 2028. The company will provide updates on site activation and enrollment initiation in the second half of 2026. Additional clinical data are expected later in 2026 from at least 20 patients with refractory rheumatoid arthritis treated in an ongoing Phase 2a basket trial, including at least 10 who meet the Phase 3 eligibility criteria. Separate disclosures will cover at least 10 patients with Sjögren disease and five with systemic sclerosis, each with a minimum six‑month follow‑up.
Artiva indicated that its cash runway extends into 2029, supporting continued development and trial execution.
The trial represents the company’s most advanced effort to bring an off‑the‑shelf NK‑cell therapy to market for autoimmune indications, pending regulatory approval based on the forthcoming Phase 3 data.
