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Taking peoplePhase 2

Tests AlloNK cell therapy with rituximab in relapsing rheumatic diseases

Tests AlloNK immune cells with rituximab in adults with relapsing arthritis or myositis.

Key facts

Who runs it
Artiva Biotherapeutics, Inc.
Where
Lisbon and Vila Nova de Gaia, PortugalSee the 2 sitesAlso in 10 other countries, 52 sites
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.
Status
Recruiting
Phase
Phase 2
People taking part
90 people, planned
Started
9 Jul 2025
Expected to end
Jan 2029
Type of study
Interventional
Treatments tested
  • Allogeneic NK Cells
Record updated
31 July 2026

Who can take part

AI summary

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).

The registry criteria, word for word

Show all 16 criteriaShow less

Other 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 in Portugal

Also in 10 other countries, 52 sites

  • Unidade Local De Saude De Santa Maria E.P.E.Lisbon, PortugalNo longer taking part
  • Unidade Local de Saúde de Gaia/Espinho, E. P. EVila Nova de Gaia, PortugalNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • AlloNKTreatment being tested

    AlloNK, dosed after a conditioning regimen, combined with Rituximab.

    Treatment: Allogeneic NK Cells

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests AlloNK cell therapy with rituximab in relapsing rheumatic diseasesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
31 July 2026