Recruiting

Phase 2

AlloNK® & RituximabAlloNK®, 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.

Sponsor:

Artiva Biotherapeutics, Inc.

Code:

NCT06991114

Conditions

Refractory Rheumatoid Arthritis (RA)

Idiopathic Inflammatory Myopathies (IIMs)

Systemic Sclerosis (SSc)

Rheumatoid Arthritis (RA

IIM

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Allogeneic NK Cells

Study Details

Brief 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.

Conditions

Refractory Rheumatoid Arthritis (RA)

Idiopathic Inflammatory Myopathies (IIMs)

Systemic Sclerosis (SSc)

Rheumatoid Arthritis (RA

IIM

Study ID

NCT06991114

Start date

Jul 9, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AlloNK

AlloNK, dosed after a conditioning regimen, combined with Rituximab.

Interventions

Allogeneic NK Cells

AlloNK, dosed after a conditioning regimen, combined with Rituximab.

Primary outcome measure

Safety [ Time Frame: From enrollment until the end of treatment at Week 104. ]

Central Contacts and Locations

Central contacts

Chanel Mansfield Director, Clinical Operations, MPH

1 858 223 7001 clinicaltrials@artivabio.com

Locations

Artiva Investigational Site Tuscaloosa

Recruiting

Tuscaloosa, Alabama, United States, 35406

Artiva Investigational Site Phoenix

Recruiting

Phoenix, Arizona, United States, 85037

Artiva Investigational Site Tucson

Recruiting

Tucson, Arizona, United States, 85748

Artiva Investigational Site Chula Vista

Recruiting

Chula Vista, California, United States, 92108

Artiva Investigational Site Covina

Recruiting

Covina, California, United States, 91723

Artiva Investigational Site Los Alamitos

Recruiting

Los Alamitos, California, United States, 90720

Artiva Investigational Site Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Artiva Investigational Site Santa Ana

Recruiting

Santa Ana, California, United States, 92706

Artiva Investigational Site Tustin

Recruiting

Tustin, California, United States, 92780

Artiva Investigational Site Jupiter

Recruiting

Jupiter, Florida, United States, 33458

Artiva Investigational Site Miami

Recruiting

Miami, Florida, United States, 33143

Artiva Investigational Site Plantation

Recruiting

Plantation, Florida, United States, 33324

Artiva Investigational Site Gainesville

Recruiting

Gainesville, Georgia, United States, 30501

Artiva Investigational Site Norcross

Recruiting

Norcross, Georgia, United States, 30092

Artiva Investigational Site Willowbrook

Recruiting

Willowbrook, Illinois, United States, 60527

Artiva Investigational Site Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Artiva Investigational Site Iowa Great Falls

Recruiting

Great Falls, Montana, United States, 59405

Artiva Investigational Site Charlotte

Recruiting

Charlotte, North Carolina, United States, 28207

Artiva Investigational Site Charlotte

Recruiting

Charlotte, North Carolina, United States, 28625

Artiva Investigational Site Statesville

Recruiting

Statesville, North Carolina, United States, 27103

Artiva Investigational Site Charleston

Recruiting

Charleston, South Carolina, United States, 29407

Artiva Investigational Site Hixson

Recruiting

Hixson, Tennessee, United States, 37343

Artiva Investigational Site Jackson

Recruiting

Jackson, Tennessee, United States, 38305

Artiva Investigational Site Arlington

Recruiting

Arlington, Texas, United States, 76012

Artiva Investigational Site Bellaire

Recruiting

Bellaire, Texas, United States, 77401

Artiva Investigational Site Irving

Recruiting

Irving, Texas, United States, 75061

Artiva Investigational Site Katy

Recruiting

Katy, Texas, United States, 77494

Artiva Investigational Site Mesquite

Recruiting

Mesquite, Texas, United States, 75150

Artiva Investigational Site Red Oak

Recruiting

Red Oak, Texas, United States, 75154

Artiva Investigational Site Woodland

Recruiting

Woodland, Texas, United States, 77382

Artiva Investigational Site Roanoke

Recruiting

Roanoke, Virginia, United States, 24016

More Information

Sponsor

Artiva Biotherapeutics, Inc.

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

Refractory Rheumatoid Arthritis
AlloNK
Idiopathic Inflammatory Myopathies
Systemic Sclerosis
Sjögren's Disease
Refractory RA
Cell Therapy
Allogeneic NK Cells
Allogeneic Cell Therapy
non-genetically modified
rituximab
cord blood cells
ADCC enhancement
outpatient
community

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Artiva Biotherapeutics, Inc. on 2026-07-31.