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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with rheumatoid arthritis that did not respond to treatment, Sjögren's disease, inflammatory muscle disease (myositis) or systemic sclerosis. It tests AlloNK cells together with rituximab.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Rheumatoid arthritis: at least six swollen and six tender joints, with raised inflammation tests. Sjögren's disease: clinESSDAI above 6 and saliva flow above 0.1 mL/min. Myositis: confirmed by muscle biopsy or muscle MRI where applicable. Systemic sclerosis: modified Rodnan skin score above 10, diagnosed within 8 years before screening.
- Earlier treatment
- Rheumatoid arthritis: at least 12 weeks of a biologic anti-rheumatic drug that did not work. Myositis and systemic sclerosis: at least 3 months of glucocorticoids and/or at least one other immunosuppressive drug with poor response or intolerance.
- Biomarker or test result
- Rheumatoid arthritis: positive Rheumatoid Factor or ACPA, and hs-CRP above 3 mg/L or ESR above 28 mm/hr. Myositis: a positive autoantibody (for example ANA above 1:80).
Read by machine on 12 November 2026.
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.