NCT06991114 · Artiva Biotherapeutics, Inc.
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.
What this study is about
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 effectiveness of AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.
View original scientific description
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.
Interventions
DRUG
Allogeneic NK Cells
AlloNK, dosed after a conditioning regimen, combined with Rituximab.
Primary outcome measures
Safety
Time frame: From enrollment until the end of treatment at Week 104.
Dose Limiting toxicities assessed in a incrementing dose design.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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 (
Where
- Tuscaloosa, Alabama
- Phoenix, Arizona
- Tucson, Arizona
- Chula Vista, California
- Covina, California
- Los Alamitos, California
- Los Angeles, California
- Santa Ana, California
- Tustin, California
- Jupiter, Florida
- Miami, Florida
- Plantation, Florida
And 18 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations