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Clinical Trials in the USA / NCT06991114
Recruiting Phase 2

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.

NCT06991114 · tracked via the Priya Life Science USA tracker
Sponsor
Artiva Biotherapeutics, Inc.
Phase
Phase 2
Started
2025-07-09
Last updated
2026-07-31

Condition(s) studied

Refractory Rheumatoid Arthritis (RA)Idiopathic Inflammatory Myopathies (IIMs)Systemic Sclerosis (SSc)Rheumatoid Arthritis (RAIIMMyositisSclerodermaSjogren SyndromeSjogrens Disease

Investigational drug(s) / intervention(s)

Allogeneic NK Cells

Allogeneic NK Cells: AlloNK, dosed after a conditioning regimen, combined with Rituximab.

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
Artiva Investigational Site Tuscaloosa Tuscaloosa Alabama Recruiting
Artiva Investigational Site Phoenix Phoenix Arizona Recruiting
Artiva Investigational Site Tucson Tucson Arizona Recruiting
Artiva Investigational Site Chula Vista Chula Vista California Recruiting
Artiva Investigational Site Covina Covina California Recruiting
Artiva Investigational Site Los Alamitos Los Alamitos California Recruiting
Artiva Investigational Site Los Angeles Los Angeles California Recruiting
Artiva Investigational Site Santa Ana Santa Ana California Recruiting
Artiva Investigational Site Tustin Tustin California Recruiting
Artiva Investigational Site Jupiter Jupiter Florida Recruiting
Artiva Investigational Site Miami Miami Florida Recruiting
Artiva Investigational Site Plantation Plantation Florida Recruiting
Artiva Investigational Site Gainesville Gainesville Georgia Recruiting
Artiva Investigational Site Norcross Norcross Georgia Recruiting
Artiva Investigational Site Willowbrook Willowbrook Illinois Recruiting
Artiva Investigational Site Iowa Iowa City Iowa Recruiting
Artiva Investigational Site Iowa Great Falls Great Falls Montana Recruiting
Artiva Investigational Site Charlotte Charlotte North Carolina Recruiting
Artiva Investigational Site Charlotte Charlotte North Carolina Recruiting
Artiva Investigational Site Statesville Statesville North Carolina Recruiting
Artiva Investigational Site Charleston Charleston South Carolina Recruiting
Artiva Investigational Site Hixson Hixson Tennessee Recruiting
Artiva Investigational Site Jackson Jackson Tennessee Recruiting
Artiva Investigational Site Arlington Arlington Texas Recruiting
Artiva Investigational Site Bellaire Bellaire Texas Recruiting
Artiva Investigational Site Irving Irving Texas Recruiting
Artiva Investigational Site Katy Katy Texas Recruiting
Artiva Investigational Site Mesquite Mesquite Texas Recruiting
Artiva Investigational Site Red Oak Red Oak Texas Recruiting
Artiva Investigational Site Woodland Woodland Texas Recruiting
Artiva Investigational Site Roanoke Roanoke Virginia Recruiting
Artiva Investigational Site Brasília Brasília Brasília Recruiting
Artiva Investigational Site Cuiabá Cuiabá Cuiabá Recruiting
Artiva Investigational Site Porto Alegre Porto Alegre Porto Alegre Recruiting
Artiva Investigational Site Rio Grande Rio Grande Porto Alegre Recruiting
Artiva Investigational Site Sao Paulo São Paulo São Paulo Recruiting
Artiva Investigational Site São Paulo São Paulo São Paulo Recruiting
Artiva Investigational Site Plovdiv Plovdiv Plovdiv Recruiting
Artiva Investigational Site Sofia Sofia Bulgaria Recruiting
Artiva Investigational Site Marseille Marseille France Recruiting

+ 12 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06991114 on ClinicalTrials.gov ↗ ← All trials in the USA