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
Artiva Biotherapeutics, Inc.
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.
Description
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 asse…
Interventions
- DrugAllogeneic NK Cells
AlloNK, dosed after a conditioning regimen, combined with Rituximab.
Locations (26)
- Artiva Investigational Site TuscaloosaTuscaloosa, Alabama
- Artiva Investigational Site PhoenixPhoenix, Arizona
- Artiva Investigational Site CovinaCovina, California
- Artiva Investigational Site Los AlamitosLos Alamitos, California
- Artiva Investigational Site AventuraAventura, Florida
- Artiva Investigational Site JupiterJupiter, Florida