AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.

Launched by ARTIVA BIOTHERAPEUTICS, INC. · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AlloNK, which uses natural killer (NK) cells derived from umbilical cord blood, combined with a medication called rituximab. The trial is aimed at patients with certain autoimmune diseases, including rheumatoid arthritis, Sjögren's disease, idiopathic inflammatory myopathies, and systemic sclerosis, who have not responded well to other treatments. Researchers want to find out if this new therapy is safe and effective in helping these patients manage their conditions.

To be eligible for the trial, participants must have a confirmed diagnosis of one of these diseases and have tried other treatments without success. For example, those with rheumatoid arthritis must have specific blood markers and evidence of active disease, while patients with Sjögren's disease need to show a certain level of disease activity. Participants will be closely monitored throughout the study to assess the treatment's impact on their symptoms and overall health. If you or a loved one is dealing with these challenging conditions and are interested in exploring new treatment options, this trial might be an opportunity worth considering.

Gender

ALL

Eligibility criteria

• For Subjects with Refractory Rheumatoid Arthritis (RA):
• • Documented diagnosis of RA, meeting the 2010 ACR/EULAR classification criteria.
• • Rheumatoid Factor (RF) or Anti Citrullinated Protein Antibody (ACPA) positive.
• • High-sensitivity C-reactive protein (hs-CRP) \> 3 mg/L or Erythrocyte Sedimentation Rate (ESR) \> 28 mm/hr.
• • Have had prior treatment for a period of at least 12 weeks with a biologic disease modifying anti-rheumatic drug and were deemed refractory by the treating physician.
• • Minimum of six swollen joint counts (SJC) and six tender joint counts (TJC) according to joint assessment.
• • For subjects with Sjögren's Disease (SjD)
• • Prior diagnosis of Primary SjD as per 2016 ACR/EULAR criteria with confirmatory diagnosis in the 24 weeks preceding screening.
• • Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) \> 6.
• • Salivary Flow Rate \> 0.1 mL/min on stimulation.
• • For subjects with Idiopathic Inflammatory Myopathies (IIMs)
• • Presence of a positive autoantibody (ANA \>1:80 or RNP or SSA/SSB or other myositis specific autoantibodies.
• • Refractory IIM as defined by inadequate response/intolerance to at least 3 months of glucocorticoids and/or at least one other immunosuppressive.
• • Muscle biopsy or muscle MRI to confirm IIM diagnosis, where applicable, within 12 months prior to enrollment.
• • For Subjects with Systemic Sclerosis (SSc)
• • Diagnosis of SSc in accordance with the ACR/EULAR 2013 classification.
• • Modified Rodnan skin score (mRSS) \> 10.
• • Initial confirmatory diagnosis within 8 years of screening.
• • Refractory SSc as defined by inadequate response/intolerance to at least 3 months of glucocorticoids and/or at least one other immunosuppressive.