Status:
RECRUITING
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.
Lead Sponsor:
Artiva Biotherapeutics, Inc.
Conditions:
Refractory Rheumatoid Arthritis (RA)
Idiopathic Inflammatory Myopathies (IIMs)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren's Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of ...
Detailed Description
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 rheu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06991114
Start Date
July 9 2025
End Date
January 1 2029
Last Update
December 24 2025
Active Locations (26)
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1
Artiva Investigational Site Tuscaloosa
Tuscaloosa, Alabama, United States, 35406
2
Artiva Investigational Site Phoenix
Phoenix, Arizona, United States, 85037
3
Artiva Investigational Site Covina
Covina, California, United States, 91723
4
Artiva Investigational Site Los Alamitos
Los Alamitos, California, United States, 90720