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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.
NCT06991114 · Artiva Biotherapeutics, Inc.
In plain English
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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
About this study
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.
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.
Study design
Enrollment target: 90 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-09
Estimated completion: 2029-01
Last updated: 2025-12-24
Interventions
Drug: Allogeneic NK Cells
Primary outcomes
- • Safety (From enrollment until the end of treatment at Week 104.)
Sponsor
Artiva Biotherapeutics, Inc. · industry
Contacts & investigators
ContactChanel Mansfield Director, Clinical Operations, MPH · contact · clinicaltrials@artivabio.com · 1 858 223 7001
InvestigatorMichael Saddekni, M.D., PgDip, BCMAS · study_director, Artiva Therapeutics
All locations (26)
Artiva Investigational Site TuscaloosaRecruiting
Tuscaloosa, Alabama, United States
Artiva Investigational Site PhoenixRecruiting
Phoenix, Arizona, United States
Artiva Investigational Site CovinaRecruiting
Covina, California, United States
Artiva Investigational Site Los AlamitosRecruiting
Los Alamitos, California, United States
Artiva Investigational Site AventuraRecruiting
Aventura, Florida, United States
Artiva Investigational Site JupiterRecruiting
Jupiter, Florida, United States
Artiva Investigational Site PlantationRecruiting
Plantation, Florida, United States
Artiva Investigational Site WillowbrookRecruiting
Willowbrook, Illinois, United States
Artiva Investigational Site IowaRecruiting
Iowa City, Iowa, United States
Artiva Investigational Site CharlotteRecruiting
Charlotte, North Carolina, United States
Artiva Investigational Site CharlotteRecruiting
Charlotte, North Carolina, United States
Artiva Investigational Site HixsonRecruiting
Hixson, Tennessee, United States
Artiva Investigational Site ArlingtonRecruiting
Arlington, Texas, United States
Artiva Investigational Site KatyRecruiting
Katy, Texas, United States
Artiva Investigational Site MesquiteRecruiting
Mesquite, Texas, United States
Artiva Investigational Site WoodlandRecruiting
Woodland, Texas, United States
Artiva Investigational Site SofiaRecruiting
Sofia, Bulgaria
Artiva Investigational Site MarseilleRecruiting
Marseille, France
Artiva Investigational Site MontpellierRecruiting
Montpellier, France
Artiva Investigational Site ToulouseRecruiting
Toulouse, France
Artiva Investigational Site MunchenRecruiting
München, Germany
Artiva Investigational Site BresciaRecruiting
Brescia, Italy
Artiva Investigational Site Vila Nova De GaiaRecruiting
Vila Nova de Gaia, Portugal
Artiva Investigational Site BucurestiRecruiting
Bucharest, Romania
Artiva Investigational Site BucharestRecruiting
Bucharest, Romania
Artiva Investigational Site SevilaRecruiting
Seville, Spain