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Refractory Rheumatoid Arthritis (RA)Phase 2NCT06991114

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.

A Phase 2 study testing Allogeneic NK Cells in people with Refractory Rheumatoid Arthritis (RA) and Idiopathic Inflammatory Myopathies (IIMs), run by Artiva Biotherapeutics, Inc. at 52 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Allogeneic NK Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
52 sitesin 11 countries
Study dates
9 Jul 2025to Jan 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

52 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Chanel Mansfield Director, Clinical Operations, MPH contact

1 858 223 7001

clinicaltrials@artivabio.com

52 sites in 11 countries

United States31 sites, 31 recruiting

  • Artiva Investigational Site Arlington

    Arlington, Texas, 76012

    Recruiting

  • Artiva Investigational Site Bellaire

    Bellaire, Texas, 77401

    Recruiting

  • Artiva Investigational Site Charleston

    Charleston, South Carolina, 29407

    Recruiting

  • Artiva Investigational Site Charlotte

    Charlotte, North Carolina, 28207

    Recruiting

  • Artiva Investigational Site Charlotte

    Charlotte, North Carolina, 28625

    Recruiting

  • Artiva Investigational Site Chula Vista

    Chula Vista, California, 92108

    Recruiting

  • Artiva Investigational Site Covina

    Covina, California, 91723

    Recruiting

  • Artiva Investigational Site Gainesville

    Gainesville, Georgia, 30501

    Recruiting

  • Artiva Investigational Site Iowa Great Falls

    Great Falls, Montana, 59405

    Recruiting

  • Artiva Investigational Site Hixson

    Hixson, Tennessee, 37343

    Recruiting

  • Artiva Investigational Site Iowa

    Iowa City, Iowa, 52242

    Recruiting

  • Artiva Investigational Site Irving

    Irving, Texas, 75061

    Recruiting

  • Artiva Investigational Site Jackson

    Jackson, Tennessee, 38305

    Recruiting

  • Artiva Investigational Site Jupiter

    Jupiter, Florida, 33458

    Recruiting

  • Artiva Investigational Site Katy

    Katy, Texas, 77494

    Recruiting

  • Artiva Investigational Site Los Alamitos

    Los Alamitos, California, 90720

    Recruiting

  • Artiva Investigational Site Los Angeles

    Los Angeles, California, 90027

    Recruiting

  • Artiva Investigational Site Mesquite

    Mesquite, Texas, 75150

    Recruiting

  • Artiva Investigational Site Miami

    Miami, Florida, 33143

    Recruiting

  • Artiva Investigational Site Norcross

    Norcross, Georgia, 30092

    Recruiting

  • Artiva Investigational Site Phoenix

    Phoenix, Arizona, 85037

    Recruiting

  • Artiva Investigational Site Plantation

    Plantation, Florida, 33324

    Recruiting

  • Artiva Investigational Site Red Oak

    Red Oak, Texas, 75154

    Recruiting

  • Artiva Investigational Site Roanoke

    Roanoke, Virginia, 24016

    Recruiting

  • Artiva Investigational Site Santa Ana

    Santa Ana, California, 92706

    Recruiting

  • Artiva Investigational Site Statesville

    Statesville, North Carolina, 27103

    Recruiting

  • Artiva Investigational Site Tucson

    Tucson, Arizona, 85748

    Recruiting

  • Artiva Investigational Site Tuscaloosa

    Tuscaloosa, Alabama, 35406

    Recruiting

  • Artiva Investigational Site Tustin

    Tustin, California, 92780

    Recruiting

  • Artiva Investigational Site Willowbrook

    Willowbrook, Illinois, 60527

    Recruiting

  • Artiva Investigational Site Woodland

    Woodland, Texas, 77382

    Recruiting

Other trials in United States

Brazil6 sites, 6 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

Other trials in Brazil

France3 sites, 3 recruiting

  • Artiva Investigational Site Marseille

    Marseille, 13005

    Recruiting

  • Artiva Investigational Site Montpellier

    Montpellier, 34090

    Recruiting

  • Artiva Investigational Site Toulouse

    Toulouse, 31059

    Recruiting

Other trials in France

Bulgaria2 sites, 2 recruiting

  • Artiva Investigational Site Plovdiv

    Plovdiv, Plovdiv

    Recruiting

  • Artiva Investigational Site Sofia

    Sofia, 1612

    Recruiting

Other trials in Bulgaria

Germany2 sites, 2 recruiting

  • Artiva Investigational Site Bonn

    Bonn, Bonn

    Recruiting

  • Artiva Investigational Site Munchen

    München, 80336

    Recruiting

Other trials in Germany

Poland2 sites, 2 recruiting

  • Artiva Investigational Site Bydgoszcz

    Bydgoszcz, Bydgoszcz

    Recruiting

  • Artiva Investigational Site Warszawa

    Warsaw, Warszawa

    Recruiting

Other trials in Poland

Romania2 sites, 2 recruiting

  • Artiva Investigational Site Bucuresti

    Bucharest, 20125

    Recruiting

  • Artiva Investigational Site Bucharest

    Bucharest, 50474

    Recruiting

Other trials in Romania

Italy1 site, 1 recruiting

  • Artiva Investigational Site Brescia

    Brescia, 25125

    Recruiting

Other trials in Italy

Portugal1 site, 1 recruiting

  • Artiva Investigational Site Vila Nova De Gaia

    Vila Nova de Gaia, 4434

    Recruiting

Other trials in Portugal

Serbia1 site, 1 recruiting

  • Artiva Investigational Site Belgrade

    Belgrade, Belgrade

    Recruiting

Other trials in Serbia

Spain1 site, 1 recruiting

  • Artiva Investigational Site Sevila

    Seville, 41701

    Recruiting

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Allogeneic NK Cells
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
Medical subject headings
Arthritis, Rheumatoid, Myositis, Scleroderma, Systemic, Scleroderma, Diffuse, Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogeneic NK CellsDrug

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

Study groups in NCT06991114
Study groupRoleWhat they receive
AlloNKExperimentalAlloNK, dosed after a conditioning regimen, combined with Rituximab.
Receives: Drug: Allogeneic NK Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    Dose Limiting toxicities assessed in a incrementing dose design.

    Measured: From enrollment until the end of treatment at Week 104.

Secondary outcomes (4)

  1. Rheumatoid Arthritis: Disease Activity Score 28 (DAS28 - ESR)

    Efficacy

    Measured: Week 52

  2. Sjögren's Disease: Improvement in Clinical EULAR Sjögren's Syndrome Disease Activity Index (ClinESSDAI)

    Efficacy

    Measured: Week 52

  3. Idiopathic Inflammatory Myopathies: Total Improvement Score (TIS)

    Efficacy

    Measured: Week 52

  4. Systemic Sclerosis: Revised Composite Response Index in Systemic Sclerosis (rCRISS)

    Efficacy

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2025
  2. Study start9 Jul 2025
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label, single group design to establish safety and efficacy.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06991114
Sponsor's protocol ID
AB-101-05
Status last verified
Jul 2026
First submitted
19 May 2025
Last updated
31 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: AlloNK is early in clinical development, next steps will be based on the progress of our data.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Allogeneic NK Cells in people with Refractory Rheumatoid Arthritis (RA) and Idiopathic Inflammatory Myopathies (IIMs), run by Artiva Biotherapeutics, Inc. at 52 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Brazil, France, Bulgaria, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chanel Mansfield Director, Clinical Operations, MPH (1 858 223 7001, clinicaltrials@artivabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: From enrollment until the end of treatment at Week 104.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06991114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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