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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.

RecruitingPhase 2Ages 18 Years - anyAllArtiva Biotherapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Allogeneic NK Cells
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Where

52 sites
Artiva Investigational Site Tuscaloosa
Tuscaloosa, United States
Artiva Investigational Site Phoenix
Phoenix, United States
Artiva Investigational Site Tucson
Tucson, United States
Artiva Investigational Site Chula Vista
Chula Vista, United States
Artiva Investigational Site Covina
Covina, United States
Artiva Investigational Site Los Alamitos
Los Alamitos, United States
Artiva Investigational Site Los Angeles
Los Angeles, United States
Artiva Investigational Site Santa Ana
Santa Ana, United States

…and 44 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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