Tests AlloNK cell therapy with rituximab in relapsing rheumatic diseases
Tests AlloNK immune cells with rituximab in adults with relapsing arthritis or myositis.
Plain-language title generated from the registry record
Registry title: 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.
Key facts
- Where
- Marseille, Montpellier, and Toulouse Cedex 9, FranceSee the 3 sites
- Phase
- Phase 2
Where in France
- Centre Hospitalier Regional De MarseilleMarseille, FranceNo longer taking part
- Hospital Saint EloiMontpellier, FranceNo longer taking part
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Artiva Biotherapeutics, Inc.
- Trial code
- NCT06991114EU 2025-520461-41-00
- Record updated
- 31 July 2026
- Original description
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 AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.Read full original descriptionShow less
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
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 AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.
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.