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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
AlloNK, dosed after a conditioning regimen, combined with Rituximab.
Artiva Investigational Site Tuscaloosa
Tuscaloosa, Alabama, United States
RECRUITINGArtiva Investigational Site Phoenix
Phoenix, Arizona, United States
RECRUITINGArtiva Investigational Site Tucson
Tucson, Arizona, United States
RECRUITINGArtiva Investigational Site Chula Vista
Chula Vista, California, United States
Safety
Dose Limiting toxicities assessed in a incrementing dose design.
Time frame: From enrollment until the end of treatment at Week 104.
Rheumatoid Arthritis: Disease Activity Score 28 (DAS28 - ESR)
Efficacy
Time frame: Week 52
Sjögren's Disease: Improvement in Clinical EULAR Sjögren's Syndrome Disease Activity Index (ClinESSDAI)
Efficacy
Time frame: Week 52
Idiopathic Inflammatory Myopathies: Total Improvement Score (TIS)
Efficacy
Time frame: Week 52
Systemic Sclerosis: Revised Composite Response Index in Systemic Sclerosis (rCRISS)
Efficacy
Time frame: Week 52
Chanel Mansfield Director, Clinical Operations, MPH
CONTACT
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Artiva Investigational Site Covina
Covina, California, United States
RECRUITINGArtiva Investigational Site Los Alamitos
Los Alamitos, California, United States
RECRUITINGArtiva Investigational Site Los Angeles
Los Angeles, California, United States
RECRUITINGArtiva Investigational Site Santa Ana
Santa Ana, California, United States
RECRUITINGArtiva Investigational Site Tustin
Tustin, California, United States
RECRUITINGArtiva Investigational Site Jupiter
Jupiter, Florida, United States
RECRUITING...and 42 more locations