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Cure My Disease

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New immune cell combo tackles tough autoimmune diseases

NCT ID NCT06991114

Disease control Sponsor: Artiva Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This phase 2 trial tests a therapy called AlloNK, made from donor cord blood immune cells, combined with the drug rituximab. It aims to see if this combination is safe and can help people with severe forms of rheumatoid arthritis, Sjögren's disease, myositis, or scleroderma that haven't responded to other treatments. About 90 participants will receive the therapy in a step-by-step dosing plan.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AlloNK (a donor immune cell therapy) combined with rituximab
What this could lead to
If it works, this could offer a new treatment option for people with hard-to-treat autoimmune diseases like rheumatoid arthritis or scleroderma.
What could go wrong
This is an early phase 2 trial with only 90 people, so results may not apply widely. The therapy involves strong immune suppression, which carries risks of infection and other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy diffuse scleroderma juvenile dermatomyositis myositis disease rheumatoid arthritis scleroderma Sjogren syndrome systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic inflammatory myopathies (IIMS) IIM Myositis Refractory rheumatoid arthritis (RA) Rheumatoid arthritis (RA) Scleroderma Sjogren syndrome Sjogrens disease Systemic sclerosis (SSC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    52 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Artiva Investigational Site Arlington

    RECRUITING

    Arlington, Texas, 76012, United States

  • Artiva Investigational Site Belgrade

    RECRUITING

    Belgrade, Belgrade, Serbia

  • Artiva Investigational Site Bellaire

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Artiva Investigational Site Bonn

    RECRUITING

    Bonn, Bonn, Germany

  • Artiva Investigational Site Brasília

    RECRUITING

    Brasília, Brasília, Brazil

  • Artiva Investigational Site Brescia

    RECRUITING

    Brescia, 25125, Italy

  • Artiva Investigational Site Bucharest

    RECRUITING

    Bucharest, 50474, Romania

  • Artiva Investigational Site Bucuresti

    RECRUITING

    Bucharest, 20125, Romania

  • Artiva Investigational Site Bydgoszcz

    RECRUITING

    Bydgoszcz, Bydgoszcz, Poland

  • Artiva Investigational Site Charleston

    RECRUITING

    Charleston, South Carolina, 29407, United States

  • Artiva Investigational Site Charlotte

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Artiva Investigational Site Charlotte

    RECRUITING

    Charlotte, North Carolina, 28625, United States

  • Artiva Investigational Site Chula Vista

    RECRUITING

    Chula Vista, California, 92108, United States

  • Artiva Investigational Site Covina

    RECRUITING

    Covina, California, 91723, United States

  • Artiva Investigational Site Cuiabá

    RECRUITING

    Cuiabá, Cuiabá, Brazil

  • Artiva Investigational Site Gainesville

    RECRUITING

    Gainesville, Georgia, 30501, United States

  • Artiva Investigational Site Hixson

    RECRUITING

    Hixson, Tennessee, 37343, United States

  • Artiva Investigational Site Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Artiva Investigational Site Iowa Great Falls

    RECRUITING

    Great Falls, Montana, 59405, United States

  • Artiva Investigational Site Irving

    RECRUITING

    Irving, Texas, 75061, United States

  • Artiva Investigational Site Jackson

    RECRUITING

    Jackson, Tennessee, 38305, United States

  • Artiva Investigational Site Jupiter

    RECRUITING

    Jupiter, Florida, 33458, United States

  • Artiva Investigational Site Katy

    RECRUITING

    Katy, Texas, 77494, United States

  • Artiva Investigational Site Los Alamitos

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Artiva Investigational Site Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Artiva Investigational Site Marseille

    RECRUITING

    Marseille, 13005, France

  • Artiva Investigational Site Mesquite

    RECRUITING

    Mesquite, Texas, 75150, United States

  • Artiva Investigational Site Miami

    RECRUITING

    Miami, Florida, 33143, United States

  • Artiva Investigational Site Montpellier

    RECRUITING

    Montpellier, 34090, France

  • Artiva Investigational Site Munchen

    RECRUITING

    München, 80336, Germany

  • Artiva Investigational Site Norcross

    RECRUITING

    Norcross, Georgia, 30092, United States

  • Artiva Investigational Site Phoenix

    RECRUITING

    Phoenix, Arizona, 85037, United States

  • Artiva Investigational Site Plantation

    RECRUITING

    Plantation, Florida, 33324, United States

  • Artiva Investigational Site Plovdiv

    RECRUITING

    Plovdiv, Plovdiv, Bulgaria

  • Artiva Investigational Site Porto Alegre

    RECRUITING

    Porto Alegre, Porto Alegre, Brazil

  • Artiva Investigational Site Red Oak

    RECRUITING

    Red Oak, Texas, 75154, United States

  • Artiva Investigational Site Rio Grande

    RECRUITING

    Rio Grande, Porto Alegre, Brazil

  • Artiva Investigational Site Roanoke

    RECRUITING

    Roanoke, Virginia, 24016, United States

  • Artiva Investigational Site Santa Ana

    RECRUITING

    Santa Ana, California, 92706, United States

  • Artiva Investigational Site Sao Paulo

    RECRUITING

    São Paulo, São Paulo, Brazil

  • Artiva Investigational Site Sevila

    RECRUITING

    Seville, 41701, Spain

  • Artiva Investigational Site Sofia

    RECRUITING

    Sofia, 1612, Bulgaria

  • Artiva Investigational Site Statesville

    RECRUITING

    Statesville, North Carolina, 27103, United States

  • Artiva Investigational Site São Paulo

    RECRUITING

    São Paulo, São Paulo, Brazil

  • Artiva Investigational Site Toulouse

    RECRUITING

    Toulouse, 31059, France

  • Artiva Investigational Site Tucson

    RECRUITING

    Tucson, Arizona, 85748, United States

  • Artiva Investigational Site Tuscaloosa

    RECRUITING

    Tuscaloosa, Alabama, 35406, United States

  • Artiva Investigational Site Tustin

    RECRUITING

    Tustin, California, 92780, United States

  • Artiva Investigational Site Vila Nova De Gaia

    RECRUITING

    Vila Nova de Gaia, 4434, Portugal

  • Artiva Investigational Site Warszawa

    RECRUITING

    Warsaw, Warszawa, Poland

  • Artiva Investigational Site Willowbrook

    RECRUITING

    Willowbrook, Illinois, 60527, United States

  • Artiva Investigational Site Woodland

    RECRUITING

    Woodland, Texas, 77382, United States

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Other studies related to the condition(s) this trial covers.