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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Florida
Artiva Investigational Site Aventura
RECRUITING
Aventura
Artiva Investigational Site Plantation
RECRUITING
Plantation
North Carolina
Artiva Investigational Site Charlotte
RECRUITING
Charlotte
Texas
Artiva Investigational Site Arlington
RECRUITING
Arlington
Artiva Investigational Site Mesquite
RECRUITING
Mesquite
Artiva Investigational Site Woodland
RECRUITING
Woodland
Contact Information
Primary
Chanel Mansfield Director, Clinical Operations, MPH
clinicaltrials@artivabio.com
1 858 223 7001
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2029-01
Participants
Target number of participants: 90
Treatments
Experimental: AlloNK
AlloNK, dosed after a conditioning regimen, combined with Rituximab.
Sponsors
Leads: Artiva Biotherapeutics, Inc.

This content was sourced from clinicaltrials.gov