ClinicalTrials.gg
RecruitingNCT06991114Updated Jul 31, 2026

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 interventional study of Allogeneic NK Cells in Refractory Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc), sponsored by Artiva Biotherapeutics, Inc.. Recruiting at 52 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Primary conditionSjogren's SyndromeRegistry: Arthritis, RheumatoidReclassifiedWhy we changed it
Registry
Arthritis, Rheumatoid — the first condition term the registry derived for this study.
ClinicalTrials.gg
Sjogren's Syndrome
Why
  1. The study's listed conditions name Sjogren's Syndrome, a narrower term within Arthritis, Rheumatoid.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Artiva Biotherapeutics, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Refractory Rheumatoid Arthritis (RA)
  • Idiopathic Inflammatory Myopathies (IIMs)
  • Systemic Sclerosis (SSc)
  • Rheumatoid Arthritis (RA
  • IIM
  • Myositis
  • Scleroderma
  • Sjogren Syndrome
  • Sjogrens Disease

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
03

In context

Sjogren's Syndrome Reclassified

330 studies on the registry are indexed under Sjogren's Syndrome; 99 are open to participants now.

This study's planned enrollment of 90 is above the median of 50 across 218 interventional studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

Artiva Biotherapeutics, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Compared within Sjogren's Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arthritis, Rheumatoid. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

For Subjects with 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 and/or at least one other .
  • Muscle 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    AlloNK

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

    Drug: Allogeneic NK Cells

Interventions

  • DrugAllogeneic NK Cells

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

06

What researchers measure

Primary outcomes

  1. Safety

    Dose Limiting toxicities assessed in a incrementing dose design.

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

Secondary outcomes

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

    Efficacy

    Time frame: Week 52

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

    Efficacy

    Time frame: Week 52

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

    Efficacy

    Time frame: Week 52

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

    Efficacy

    Time frame: Week 52

07

Study locations

52 of 52 sites 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
  • Artiva Investigational Site Covina
    Covina, California 91723, United States
    Recruiting
  • Artiva Investigational Site Los Alamitos
    Los Alamitos, California 90720, United States
    Recruiting
  • Artiva Investigational Site Los Angeles
    Los Angeles, California 90027, United States
    Recruiting
  • Artiva Investigational Site Santa Ana
    Santa Ana, California 92706, United States
    Recruiting
  • Artiva Investigational Site Tustin
    Tustin, California 92780, United States
    Recruiting
  • Artiva Investigational Site Jupiter
    Jupiter, Florida 33458, United States
    Recruiting
  • Artiva Investigational Site Miami
    Miami, Florida 33143, United States
    Recruiting
  • Artiva Investigational Site Plantation
    Plantation, Florida 33324, United States
    Recruiting
  • Artiva Investigational Site Gainesville
    Gainesville, Georgia 30501, United States
    Recruiting
  • Artiva Investigational Site Norcross
    Norcross, Georgia 30092, United States
    Recruiting
  • Artiva Investigational Site Willowbrook
    Willowbrook, Illinois 60527, United States
    Recruiting
  • Artiva Investigational Site Iowa
    Iowa City, Iowa 52242, United States
    Recruiting
  • Artiva Investigational Site Iowa Great Falls
    Great Falls, Montana 59405, United States
    Recruiting
  • Artiva Investigational Site Charlotte
    Charlotte, North Carolina 28207, United States
    Recruiting
  • Artiva Investigational Site Charlotte
    Charlotte, North Carolina 28625, United States
    Recruiting
  • Artiva Investigational Site Statesville
    Statesville, North Carolina 27103, United States
    Recruiting
  • Artiva Investigational Site Charleston
    Charleston, South Carolina 29407, United States
    Recruiting
  • Artiva Investigational Site Hixson
    Hixson, Tennessee 37343, United States
    Recruiting
  • Artiva Investigational Site Jackson
    Jackson, Tennessee 38305, United States
    Recruiting
  • Artiva Investigational Site Arlington
    Arlington, Texas 76012, United States
    Recruiting
  • Artiva Investigational Site Bellaire
    Bellaire, Texas 77401, United States
    Recruiting
  • Artiva Investigational Site Irving
    Irving, Texas 75061, United States
    Recruiting
  • Artiva Investigational Site Katy
    Katy, Texas 77494, United States
    Recruiting
  • Artiva Investigational Site Mesquite
    Mesquite, Texas 75150, United States
    Recruiting
  • Artiva Investigational Site Red Oak
    Red Oak, Texas 75154, United States
    Recruiting
  • Artiva Investigational Site Woodland
    Woodland, Texas 77382, United States
    Recruiting
  • Artiva Investigational Site Roanoke
    Roanoke, Virginia 24016, United States
    Recruiting
  • 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 Bucuresti
    Bucharest, 20125, Romania
    Recruiting
  • Artiva Investigational Site Bucharest
    Bucharest, 50474, Romania
    Recruiting
  • Artiva Investigational Site Belgrade
    Belgrade, Belgrade, Serbia
    Recruiting
  • Artiva Investigational Site Sevila
    Seville, 41701, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — AlloNK is early in clinical development, next steps will be based on the progress of our data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06991114
Lead sponsor
Artiva Biotherapeutics, Inc.
Responsible party
Sponsor
First posted
May 25, 2025
Start date
Jul 9, 2025
Primary completion
Jan 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Jul 31, 2026

Study contacts

Chanel Mansfield Director, Clinical Operations, MPH
Contact
clinicaltrials@artivabio.com
1 858 223 7001
Michael Saddekni, M.D., PgDip, BCMAS
study director · Artiva Therapeutics

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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