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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.

NCT ID: NCT06991114
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Artiva Biotherapeutics, Inc.
Conditions: Idiopathic Inflammatory Myopathies (IIMs), IIM, Myositis, Refractory Rheumatoid Arthritis (RA), Rheumatoid Arthritis (RA, Scleroderma, Sjogren Syndrome, Sjogrens Disease, Systemic Sclerosis (SSc)

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 90 participants (Estimated).

What is being studied

Drug: Allogeneic NK Cells

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility 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.

Study locations

51 study locations are listed.

Recruiting site status is explicitly provided for 51 locations; 51 are listed as Recruiting.

Countries: Brazil, Bulgaria, France, Germany, Italy, Poland, Portugal, Romania, Serbia, Spain, United States

Brasília, Brazil: 1
Cuiabá, Brazil: 1
Porto Alegre, Brazil: 2
São Paulo, Brazil: 2
Plovdiv, Bulgaria: 1
Bonn, Germany: 1
Bydgoszcz, Poland: 1
Warszawa, Poland: 1
Belgrade, Serbia: 1
Alabama, United States: 1
Arizona, United States: 2
California, United States: 6
Florida, United States: 3
Georgia, United States: 2
Illinois, United States: 1
Iowa, United States: 1
Montana, United States: 1
North Carolina, United States: 2
South Carolina, United States: 1
Tennessee, United States: 2
Texas, United States: 7
Virginia, United States: 1

Sample of listed locations

Artiva Investigational Site Brasília — Brasília, Brasília, Brazil — Recruiting
Artiva Investigational Site Cuiabá — Cuiabá, Cuiabá, Brazil — Recruiting
Artiva Investigational Site Porto Alegre — Porto Alegre, Porto Alegre, Brazil — Recruiting
Artiva Investigational Site Rio Grande — Rio Grande, Porto Alegre, Brazil — Recruiting
Artiva Investigational Site Sao Paulo — São Paulo, São Paulo, Brazil — Recruiting
Artiva Investigational Site São Paulo — São Paulo, São Paulo, Brazil — Recruiting
Artiva Investigational Site Plovdiv — Plovdiv, Plovdiv, Bulgaria — Recruiting
Artiva Investigational Site Sofia — Sofia, 1612, Bulgaria — Recruiting
Artiva Investigational Site Marseille — Marseille, 13005, France — Recruiting
Artiva Investigational Site Montpellier — Montpellier, 34090, France — Recruiting
Artiva Investigational Site Toulouse — Toulouse, 31059, France — Recruiting
Artiva Investigational Site Bonn — Bonn, Bonn, Germany — Recruiting
Artiva Investigational Site Munchen — München, 80336, Germany — Recruiting
Artiva Investigational Site Brescia — Brescia, 25125, Italy — Recruiting
Artiva Investigational Site Bydgoszcz — Bydgoszcz, Bydgoszcz, Poland — Recruiting
Artiva Investigational Site Warszawa — Warsaw, Warszawa, Poland — Recruiting
Artiva Investigational Site Vila Nova De Gaia — Vila Nova de Gaia, 4434, Portugal — Recruiting
Artiva Investigational Site Bucharest — Bucharest, 50474, Romania — Recruiting
Artiva Investigational Site Bucuresti — Bucharest, 20125, Romania — Recruiting
Artiva Investigational Site Belgrade — Belgrade, Belgrade, Serbia — Recruiting
Artiva Investigational Site Sevila — Seville, 41701, Spain — Recruiting
Artiva Investigational Site Tuscaloosa — Tuscaloosa, Alabama, 35406, United States — Recruiting
Artiva Investigational Site Phoenix — Phoenix, Arizona, 85037, United States — Recruiting
Artiva Investigational Site Tucson — Tucson, Arizona, 85748, United States — Recruiting
Artiva Investigational Site Chula Vista — Chula Vista, California, 92108, United States — Recruiting

Study details

Start date: July 9, 2025
Primary completion date: January 1, 2028
Completion date: January 1, 2029
First posted: May 25, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06991114
Registry last updated: July 31, 2026
QualifiedStudies registry data refreshed: October 2, 2026
QualifiedStudies record fetched: October 2, 2026

View NCT06991114 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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