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NCT06991114PHASE2Recruiting

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.

Artiva Biotherapeutics, Inc.

Start Date

7/9/2025

Completion Date

1/1/2029

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Allogeneic NK Cells

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Conditions

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

Locations

Artiva Investigational Site Tuscaloosa

Tuscaloosa, Alabama 35406

United States

Artiva Investigational Site Phoenix

Phoenix, Arizona 85037

United States

Artiva Investigational Site Tucson

Tucson, Arizona 85748

United States

Artiva Investigational Site Chula Vista

Chula Vista, California 92108

United States

Artiva Investigational Site Covina

Covina, California 91723

United States

Artiva Investigational Site Los Alamitos

Los Alamitos, California 90720

United States

Artiva Investigational Site Los Angeles

Los Angeles, California 90027

United States

Artiva Investigational Site Santa Ana

Santa Ana, California 92706

United States

Artiva Investigational Site Tustin

Tustin, California 92780

United States

Artiva Investigational Site Jupiter

Jupiter, Florida 33458

United States

Artiva Investigational Site Miami

Miami, Florida 33143

United States

Artiva Investigational Site Plantation

Plantation, Florida 33324

United States

Artiva Investigational Site Gainesville

Gainesville, Georgia 30501

United States

Artiva Investigational Site Norcross

Norcross, Georgia 30092

United States

Artiva Investigational Site Willowbrook

Willowbrook, Illinois 60527

United States

Artiva Investigational Site Iowa

Iowa City, Iowa 52242

United States

Artiva Investigational Site Iowa Great Falls

Great Falls, Montana 59405

United States

Artiva Investigational Site Charlotte

Charlotte, North Carolina 28207

United States

Artiva Investigational Site Charlotte

Charlotte, North Carolina 28625

United States

Artiva Investigational Site Statesville

Statesville, North Carolina 27103

United States

Artiva Investigational Site Charleston

Charleston, South Carolina 29407

United States

Artiva Investigational Site Hixson

Hixson, Tennessee 37343

United States

Artiva Investigational Site Jackson

Jackson, Tennessee 38305

United States

Artiva Investigational Site Arlington

Arlington, Texas 76012

United States

Artiva Investigational Site Bellaire

Bellaire, Texas 77401

United States

Artiva Investigational Site Irving

Irving, Texas 75061

United States

Artiva Investigational Site Katy

Katy, Texas 77494

United States

Artiva Investigational Site Mesquite

Mesquite, Texas 75150

United States

Artiva Investigational Site Red Oak

Red Oak, Texas 75154

United States

Artiva Investigational Site Woodland

Woodland, Texas 77382

United States

Artiva Investigational Site Roanoke

Roanoke, Virginia 24016

United States

Artiva Investigational Site Brasília

Brasília, Brasília

Brazil

Artiva Investigational Site Cuiabá

Cuiabá, Cuiabá

Brazil

Artiva Investigational Site Porto Alegre

Porto Alegre, Porto Alegre

Brazil

Artiva Investigational Site Rio Grande

Rio Grande, Porto Alegre

Brazil

Artiva Investigational Site Sao Paulo

São Paulo, São Paulo

Brazil

Artiva Investigational Site São Paulo

São Paulo, São Paulo

Brazil

Artiva Investigational Site Plovdiv

Plovdiv, Plovdiv

Bulgaria

Artiva Investigational Site Sofia

Sofia, 1612

Bulgaria

Artiva Investigational Site Marseille

Marseille, 13005

France

Artiva Investigational Site Montpellier

Montpellier, 34090

France

Artiva Investigational Site Toulouse

Toulouse, 31059

France

Artiva Investigational Site Bonn

Bonn, Bonn

Germany

Artiva Investigational Site Munchen

München, 80336

Germany

Artiva Investigational Site Brescia

Brescia, 25125

Italy

Artiva Investigational Site Bydgoszcz

Bydgoszcz, Bydgoszcz

Poland

Artiva Investigational Site Warszawa

Warsaw, Warszawa

Poland

Artiva Investigational Site Vila Nova De Gaia

Vila Nova de Gaia, 4434

Portugal

Artiva Investigational Site Bucuresti

Bucharest, 20125

Romania

Artiva Investigational Site Bucharest

Bucharest, 50474

Romania

Artiva Investigational Site Belgrade

Belgrade, Belgrade

Serbia

Artiva Investigational Site Sevila

Seville, 41701

Spain