Pipeline

CONCERT-RA™: A Phase 3 Trial of AlloNK + Rituximab in Refractory RA

Many patients with rheumatoid arthritis continue to have active disease after having an inadequate response to multiple biologic or targeted synthetic disease-modifying anti-rheumatic drugs, or b/tsDMARDs. As response rates decline with successive treatments, patients are often left cycling through therapies without achieving adequate disease control.

Artiva estimates that approximately 150,000 to 200,000 patients in the United States have had an inadequate response to at least two distinct b/tsDMARD classes. Real-world registry analyses and published data suggest that patients in this setting only have an 11% to 19% likelihood of achieving an ACR50 response with currently available therapies.

The Phase 3 CONCERT-RA trial is expected to enroll approximately 150 patients who have had an inadequate response to at least two distinct classes of b/tsDMARDs. Patients will be randomized 2:1 to receive AlloNK plus rituximab or rituximab alone, with ACR50 response at six months as the primary efficacy endpoint. Patients in the rituximab-alone arm who do not respond are expected to have the opportunity to cross over to AlloNK plus rituximab at six months.

AlloNK plus rituximab has received both Fast Track and Regenerative Medicine Advanced Therapy designations from the FDA for refractory RA. RMAT designation provides access to expedited development and review mechanisms, including increased opportunities for FDA interaction.

Initial Clinical Data in Refractory RA

Patients included in Artiva’s initial RA dataset had long-standing, highly active disease and had received multiple prior targeted therapies. In the company-sponsored Phase 2a basket trial, as of April 3, 2026, five of seven patients with six months of follow-up achieved an ACR50 response. Improvements were also observed across swollen and tender joint counts, CDAI, DAS28-ESR and other ACR measures.

Company-Sponsored Phase 2a Basket Trial

Using Clinical and Translational Data to Guide Expansion

Artiva’s ongoing company-sponsored Phase 2a basket trial is evaluating AlloNK plus rituximab in refractory RA, Sjögren disease, systemic sclerosis and myositis. The study is generating clinical, safety and translational data to identify the autoimmune diseases in which deep B-cell depletion may have the greatest impact and to inform development beyond refractory RA.

In addition to the initial clinical data in refractory RA, patients with Sjögren disease (n=11) demonstrated improvements across clinical, patient-reported and functional measures, including normalization of mean stimulated salivary flow among patients with six months of follow-up (n=7) as of April 3, 2026. Patients with systemic sclerosis (n=5) demonstrated improvements in mean modified Rodnan skin score (mRSS); among patients with six months of follow-up (n=4), mRSS decreased by 9.5 points on average, and all achieved rCRISS25 as of April 3, 2026.

Across the autoimmune dataset, treatment produced uniform and consistent B-cell depletion by Day 13 in 51 evaluable patients, with reconstitution characterized by a predominance of naïve and transitional B cells. No CRS or ICANS was observed among the 55 patients included in the safety analysis as of April 3, 2026.

These data are early and require confirmation in larger studies. The initial clinical activity appears in line with that reported for autologous CAR T approaches, although additional follow-up is needed to assess durability and the potential role of repeat treatment.

Investigator-Initiated Autoimmune Basket Trial

Establishing Early Clinical Proof of Concept in Refractory RA

The investigator-initiated autoimmune basket trial generated Artiva’s first clinical experience with AlloNK plus rituximab in refractory RA and other B-cell-driven autoimmune diseases. Early findings in heavily pretreated patients provided initial evidence of deep B-cell depletion and clinical activity in RA, helping establish proof of concept for this patient population.

Clinical and translational observations from the trial, including the depth of B-cell depletion, clinical response and pattern of B-cell reconstitution, helped inform Artiva’s company-sponsored Phase 2a study and Phase 3 registrational strategy in refractory RA.

Clinical Foundation in Oncology

Early Clinical Experience Informed Artiva’s Autoimmune Strategy

AlloNK was first evaluated in B-cell-driven malignancies in combination with antibody-based targeting agents. This work established clinical experience with AlloNK in combination with antibody-based targeting agents and generated deep B-cell depletion activity, durability, safety and outpatient administration data that helped inform its development in autoimmune disease.

In heavily pretreated, CAR T-naïve patients with aggressive B-cell non-Hodgkin lymphoma, AlloNK plus rituximab achieved a 62% complete response rate in 13 patients. Median duration of response had not been reached and was at least 19.4 months as of March 7, 2025. In a separate study in relapsed or refractory Hodgkin lymphoma, AlloNK combined with a CD30-targeting NK cell engager achieved a 58% complete response rate in 24 patients.

These studies showed that AlloNK could amplify the activity of different antibody-based targeting agents and helped establish the clinical and manufacturing foundation for Artiva’s current focus on B-cell-driven autoimmune diseases.