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 | Recruiting Phase 2 FDA Drug

• 1 other identifier: AB-101-05
• Study Type: interventional
• Target: 90
• Locations: 8 countries
• Sites: 26

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety

  Dose Limiting toxicities assessed in a incrementing dose design.

  From enrollment until the end of treatment at Week 104.

Secondary Outcomes (4)

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

  Week 52

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

  Week 52

• Idiopathic Inflammatory Myopathies: Total Improvement Score (TIS)

  Week 52

• Systemic Sclerosis: Revised Composite Response Index in Systemic Sclerosis (rCRISS)

  Week 52

Study Arms (1)

AlloNK

EXPERIMENTAL

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

Drug: Allogeneic NK Cells

Interventions

Allogeneic NK Cells DRUG

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

AlloNK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Artiva Biotherapeutics, Inc.: lead

Study Sites (26)

Artiva Investigational Site Tuscaloosa

Tuscaloosa, Alabama, 35406, United States

RECRUITING

Artiva Investigational Site Phoenix

Phoenix, Arizona, 85037, 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 Aventura

Aventura, Florida, 33180, United States

RECRUITING

Artiva Investigational Site Jupiter

Jupiter, Florida, 33458, United States

RECRUITING

Artiva Investigational Site Plantation

Plantation, Florida, 33324, 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 Charlotte

Charlotte, North Carolina, 28207, United States

RECRUITING

Artiva Investigational Site Charlotte

Charlotte, North Carolina, 28625, United States

RECRUITING

Artiva Investigational Site Hixson

Hixson, Tennessee, 37343, United States

RECRUITING

Artiva Investigational Site Arlington

Arlington, Texas, 76012, 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 Woodland

Woodland, Texas, 77382, United States

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 Munchen

München, 80336, Germany

RECRUITING

Artiva Investigational Site Brescia

Brescia, 25125, Italy

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 Sevila

Seville, 41701, Spain

RECRUITING

Related Links

• Artiva AlloNK Basket Trial site.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Myositis; Scleroderma, Systemic; Scleroderma, Diffuse; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Michael Saddekni, M.D., PgDip, BCMAS

  Artiva Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Chanel Mansfield Director, Clinical Operations, MPH

CONTACT

1 858 223 7001; clinicaltrials@artivabio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, single group design to establish safety and efficacy.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 25, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (3); ES (1); DE (1); PT (1); IT (1); RO (2); US (16); BU (1)