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
- Arlington, Bellaire, Charleston, Charlotte, Chula Vista, Covina, Gainesville, Great Falls, Hixson, Iowa City, Irving, Jackson, Jupiter, Katy, Los Alamitos, Los Angeles, Mesquite, Miami, Norcross, Phoenix, Plantation, Red Oak, Roanoke, Santa Ana, Statesville, Tucson, Tuscaloosa, Tustin, Willowbrook, and Woodland, United StatesSee the 30 sites
- Phase
- Phase 2
Where in United States
- Artiva Investigational Site ArlingtonArlington, United StatesTaking people
- Artiva Investigational Site BellaireBellaire, United StatesTaking people
- Artiva Investigational Site CharlestonCharleston, United StatesTaking people
- Artiva Investigational Site CharlotteCharlotte, United StatesTaking people
- Artiva Investigational Site Chula VistaChula Vista, United StatesTaking people
- Artiva Investigational Site CovinaCovina, United StatesTaking people
- Artiva Investigational Site GainesvilleGainesville, United StatesTaking people
- Artiva Investigational Site Iowa Great FallsGreat Falls, United StatesTaking people
- Artiva Investigational Site HixsonHixson, United StatesTaking people
- Artiva Investigational Site IowaIowa City, United StatesTaking people
- Artiva Investigational Site IrvingIrving, United StatesTaking people
- Artiva Investigational Site JacksonJackson, United StatesTaking people
- Artiva Investigational Site JupiterJupiter, United StatesTaking people
- Artiva Investigational Site KatyKaty, United StatesTaking people
- Artiva Investigational Site Los AlamitosLos Alamitos, United StatesTaking people
- Artiva Investigational Site Los AngelesLos Angeles, United StatesTaking people
- Artiva Investigational Site MesquiteMesquite, United StatesTaking people
- Artiva Investigational Site MiamiMiami, United StatesTaking people
- Artiva Investigational Site NorcrossNorcross, United StatesTaking people
- Artiva Investigational Site PhoenixPhoenix, United StatesTaking people
- Artiva Investigational Site PlantationPlantation, United StatesTaking people
- Artiva Investigational Site Red OakRed Oak, United StatesTaking people
- Artiva Investigational Site RoanokeRoanoke, United StatesTaking people
- Artiva Investigational Site Santa AnaSanta Ana, United StatesTaking people
- Artiva Investigational Site StatesvilleStatesville, United StatesTaking people
- Artiva Investigational Site TucsonTucson, United StatesTaking people
- Artiva Investigational Site TuscaloosaTuscaloosa, United StatesTaking people
- Artiva Investigational Site TustinTustin, United StatesTaking people
- Artiva Investigational Site WillowbrookWillowbrook, United StatesTaking people
- Artiva Investigational Site WoodlandWoodland, United StatesTaking people
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.