AlloNK® therapy combined with rituximab for treating certain autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Artiva Investigational Site Tuscaloosa
  Tuscaloosa, Alabama, United States Recruiting
• Artiva Investigational Site Phoenix
  Phoenix, Arizona, United States Recruiting
• Artiva Investigational Site Tucson
  Tucson, Arizona, United States Recruiting
• Artiva Investigational Site Chula Vista
  Chula Vista, California, United States Recruiting
• Artiva Investigational Site Covina
  Covina, California, United States Recruiting
• Artiva Investigational Site Los Alamitos
  Los Alamitos, California, United States Recruiting

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Chanel Mansfield Director, Clinical Operations, MPH
• Email: clinicaltrials@artivabio.com
• Phone: 1 858 223 7001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.