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.
NCT ID: NCT06991114
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-07-09
2029-01-31
Brief Summary
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Detailed Description
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AlloNK® (also known as AB-101) is a non-genetically modified, allogeneic, off-the-shelf, cryopreserved cord blood-derived NK cell therapy.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AlloNK
AlloNK, dosed after a conditioning regimen, combined with Rituximab.
Allogeneic NK Cells
AlloNK, dosed after a conditioning regimen, combined with Rituximab.
Interventions
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Allogeneic NK Cells
AlloNK, dosed after a conditioning regimen, combined with Rituximab.
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Artiva Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Saddekni, M.D., PgDip, BCMAS
Role: STUDY_DIRECTOR
Artiva Therapeutics
Locations
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Artiva Investigational Site Tuscaloosa
Tuscaloosa, Alabama, United States
Artiva Investigational Site Phoenix
Phoenix, Arizona, United States
Artiva Investigational Site Covina
Covina, California, United States
Artiva Investigational Site Los Alamitos
Los Alamitos, California, United States
Artiva Investigational Site Aventura
Aventura, Florida, United States
Artiva Investigational Site Jupiter
Jupiter, Florida, United States
Artiva Investigational Site Plantation
Plantation, Florida, United States
Artiva Investigational Site Willowbrook
Willowbrook, Illinois, United States
Artiva Investigational Site Iowa
Iowa City, Iowa, United States
Artiva Investigational Site Charlotte
Charlotte, North Carolina, United States
Artiva Investigational Site Charlotte
Charlotte, North Carolina, United States
Artiva Investigational Site Hixson
Hixson, Tennessee, United States
Artiva Investigational Site Arlington
Arlington, Texas, United States
Artiva Investigational Site Katy
Katy, Texas, United States
Artiva Investigational Site Mesquite
Mesquite, Texas, United States
Artiva Investigational Site Woodland
Woodland, Texas, United States
Artiva Investigational Site Sofia
Sofia, , Bulgaria
Artiva Investigational Site Marseille
Marseille, , France
Artiva Investigational Site Montpellier
Montpellier, , France
Artiva Investigational Site Toulouse
Toulouse, , France
Artiva Investigational Site Munchen
München, , Germany
Artiva Investigational Site Brescia
Brescia, , Italy
Artiva Investigational Site Vila Nova De Gaia
Vila Nova de Gaia, , Portugal
Artiva Investigational Site Bucuresti
Bucharest, , Romania
Artiva Investigational Site Bucharest
Bucharest, , Romania
Artiva Investigational Site Sevila
Seville, , Spain
Countries
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Central Contacts
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Related Links
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Artiva AlloNK Basket Trial site.
Other Identifiers
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AB-101-05
Identifier Type: -
Identifier Source: org_study_id
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