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.

Last updated: December 23, 2025
Sponsor: Artiva Biotherapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Sjogren's Syndrome

Joint Injuries

Lupus

Treatment

Allogeneic NK Cells

Clinical Study ID

NCT06991114
AB-101-05
  • Ages > 18
  • All Genders

Study 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 AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.

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.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Allogeneic NK Cells
Phase: 2
Study Start date:
July 09, 2025
Estimated Completion Date:
January 31, 2029

Study 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 rheumatologic diseases.

AlloNK® (also known as AB-101) is a non-genetically modified, allogeneic, off-the-shelf, cryopreserved cord blood-derived NK cell therapy.

Connect with a study center

  • Artiva Investigational Site Sofia

    Sofia 727011, 1612
    Bulgaria

    Active - Recruiting

  • Artiva Investigational Site Marseille

    Marseille 2995469, 13005
    France

    Active - Recruiting

  • Artiva Investigational Site Montpellier

    Montpellier 2992166, 34090
    France

    Active - Recruiting

  • Artiva Investigational Site Toulouse

    Toulouse 2972315, 31059
    France

    Active - Recruiting

  • Artiva Investigational Site Munchen

    München 2867711, 80336
    Germany

    Active - Recruiting

  • Artiva Investigational Site Brescia

    Brescia 3181554, 25125
    Italy

    Active - Recruiting

  • Artiva Investigational Site Vila Nova De Gaia

    Vila Nova de Gaia 2732544, 4434
    Portugal

    Active - Recruiting

  • Artiva Investigational Site Bucharest

    Bucharest 683506, 50474
    Romania

    Active - Recruiting

  • Artiva Investigational Site Bucuresti

    Bucharest 683506, 20125
    Romania

    Active - Recruiting

  • Artiva Investigational Site Sevila

    Seville 2510911, 41701
    Spain

    Active - Recruiting

  • Artiva Investigational Site Tuscaloosa

    Tuscaloosa 4094455, Alabama 4829764 35406
    United States

    Active - Recruiting

  • Artiva Clinical Trial Site

    Tucson, Arizona 85748
    United States

    Site Not Available

  • Artiva Investigational Site Phoenix

    Phoenix 5308655, Arizona 5551752 85037
    United States

    Active - Recruiting

  • Artiva Investigational Site Covina

    Covina 5340175, California 5332921 91723
    United States

    Active - Recruiting

  • Artiva Investigational Site Los Alamitos

    Los Alamitos 5368304, California 5332921 90720
    United States

    Active - Recruiting

  • Artiva Clinical Trial Site

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • Artiva Investigational Site Aventura

    Aventura, Florida 33180
    United States

    Site Not Available

  • Artiva Clinical Trial Site

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Artiva Investigational Site Plantation

    Plantation, Florida 33324
    United States

    Site Not Available

  • Artiva Investigational Site Aventura

    Aventura 4146429, Florida 4155751 33180
    United States

    Active - Recruiting

  • Artiva Investigational Site Jupiter

    Jupiter 4160610, Florida 4155751 33458
    United States

    Active - Recruiting

  • Artiva Investigational Site Plantation

    Plantation 4168782, Florida 4155751 33324
    United States

    Active - Recruiting

  • Artiva Clinical Trial Site

    Willowbrook, Illinois 60527
    United States

    Site Not Available

  • Artiva Investigational Site Willowbrook

    Willowbrook 4916709, Illinois 4896861 60527
    United States

    Active - Recruiting

  • Artiva Investigational Site Iowa

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • Artiva Clinical Trial Site

    Charlotte, North Carolina 28625
    United States

    Active - Recruiting

  • Artiva Investigational Site Charlotte

    Charlotte, North Carolina 28625
    United States

    Site Not Available

  • Artiva Investigational Site Charlotte

    Charlotte 4460243, North Carolina 4482348 28625
    United States

    Active - Recruiting

  • Artiva Investigational Site Hixson

    Hixson 4629825, Tennessee 4662168 37343
    United States

    Active - Recruiting

  • Artiva Clinical Trial Site

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • Artiva Investigational Site Arlington

    Arlington, Texas 76012
    United States

    Site Not Available

  • Artiva Clinical Trial Site

    Houston, Texas 83506
    United States

    Site Not Available

  • Artiva Clinical Trial Site

    Mesquite, Texas 75150
    United States

    Active - Recruiting

  • Artiva Investigational Site Mesquite

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Artiva Clinical Trial Site

    Woodland, Texas 77382
    United States

    Active - Recruiting

  • Artiva Investigational Site Woodland

    Woodland, Texas 77382
    United States

    Site Not Available

  • Artiva Investigational Site Arlington

    Arlington 4671240, Texas 4736286 76012
    United States

    Active - Recruiting

  • Artiva Investigational Site Katy

    Katy 4702732, Texas 4736286 77494
    United States

    Active - Recruiting

  • Artiva Investigational Site Mesquite

    Mesquite 4710826, Texas 4736286 75150
    United States

    Active - Recruiting

  • Artiva Investigational Site Woodland

    Woodland 4742924, Texas 4736286 77382
    United States

    Active - Recruiting

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