Home › Trials › NCT06991114

AlloNK® therapy combined with rituximab for treating certain autoimmune diseases

An Open-label Phase 2a Study to Evaluate the Safety and Efficacy of AlloNK®, an Allogeneic Cord Blood-derived NK Cell Therapy, in Combination With Rituximab in Relapsing Forms of B-cell Dependent Rheumatologic Diseases

PHASE2 · Artiva Biotherapeutics, Inc. · NCT06991114

This study is testing if a new treatment called AlloNK® combined with rituximab can help people with tough-to-treat autoimmune diseases feel better.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment90 (estimated)
Ages18 Years and up
SexAll
SponsorArtiva Biotherapeutics, Inc. (industry)
Drugs / interventionsrituximab
Locations26 sites (Tuscaloosa, Alabama and 25 other locations)
Trial IDNCT06991114 on ClinicalTrials.gov

What this trial studies

This Phase 2a open-label trial evaluates the safety and efficacy of AlloNK®, a non-genetically modified, allogeneic NK cell therapy derived from cord blood, in combination with rituximab for patients with refractory forms of B-cell dependent rheumatologic diseases. The study focuses on conditions such as refractory rheumatoid arthritis, Sjögren's disease, idiopathic inflammatory myopathies, and systemic sclerosis. Participants will receive AlloNK® to assess its potential benefits in managing their autoimmune conditions.

Who should consider this trial

Good fit: Ideal candidates include individuals with refractory rheumatoid arthritis, Sjögren's disease, idiopathic inflammatory myopathies, or systemic sclerosis who have not responded to previous treatments.

Not a fit: Patients with non-refractory autoimmune diseases or those who do not meet the specific eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients suffering from refractory autoimmune diseases.

How similar studies have performed: While this approach is innovative, similar studies using NK cell therapies have shown promise, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Tuscaloosa, Alabama and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Refractory Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Rheumatoid Arthritis (RA, IIM, Myositis, Scleroderma, Sjogren Syndrome

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.