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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.

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Artiva Biotherapeutics, Inc. · Participants: 90 · Started: Jul 9, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06991114

Locations in the U.S.

AlabamaArtiva Investigational Site Tuscaloosa, Tuscaloosa
ArizonaArtiva Investigational Site Phoenix, Phoenix
Artiva Investigational Site Tucson, Tucson
CaliforniaArtiva Investigational Site Chula Vista, Chula Vista
Artiva Investigational Site Covina, Covina
Artiva Investigational Site Los Alamitos, Los Alamitos
Artiva Investigational Site Los Angeles, Los Angeles
Artiva Investigational Site Santa Ana, Santa Ana
Artiva Investigational Site Tustin, Tustin
FloridaArtiva Investigational Site Jupiter, Jupiter
Artiva Investigational Site Miami, Miami
Artiva Investigational Site Plantation, Plantation
GeorgiaArtiva Investigational Site Gainesville, Gainesville
Artiva Investigational Site Norcross, Norcross
IllinoisArtiva Investigational Site Willowbrook, Willowbrook
IowaArtiva Investigational Site Iowa, Iowa City
MontanaArtiva Investigational Site Iowa Great Falls, Great Falls
North CarolinaArtiva Investigational Site Charlotte, Charlotte
Artiva Investigational Site Charlotte, Charlotte
Artiva Investigational Site Statesville, Statesville
South CarolinaArtiva Investigational Site Charleston, Charleston
TennesseeArtiva Investigational Site Hixson, Hixson
Artiva Investigational Site Jackson, Jackson
TexasArtiva Investigational Site Arlington, Arlington
Artiva Investigational Site Bellaire, Bellaire
Artiva Investigational Site Irving, Irving
Artiva Investigational Site Katy, Katy
Artiva Investigational Site Mesquite, Mesquite
Artiva Investigational Site Red Oak, Red Oak
Artiva Investigational Site Woodland, Woodland
VirginiaArtiva Investigational Site Roanoke, Roanoke

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.