Refractory Rheumatoid Arthritis study: Allogeneic NK Cells
Official title 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.
ClinicalTrials.gov ID: NCT06991114
What this study is testing
What is AlloNK?
An investigational cell therapy being studied for refractory rheumatoid arthritis and other B‑cell dependent rheumatologic diseases.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether AlloNK plus rituximab is safe and how well it works for people with certain rheumatic diseases that have not responded to other treatments.
- Who it's for
- You may be able to join if you have a hard‑to‑treat form of rheumatoid arthritis, Sjögren’s disease, inflammatory muscle disease, or systemic sclerosis.
- What's involved
- You will receive a special cell therapy from cord blood and the drug rituximab. You will have visits for blood tests and check‑ups to see how you feel and if there are any side effects.
- Time commitment
- The study lasts about 6 months, with several clinic visits and blood tests during that time.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Minimum of six swollen joint counts (SJC) and six tender joint counts (TJC) according to joint assessment. For people with Sjögren's Disease (SjD)
See the full eligibility criteria
- 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 people 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 people 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 people 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Tuscaloosa, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Chula Vista, California, United States
- Covina, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Santa Ana, California, United States
- Tustin, California, United States
- Jupiter, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Gainesville, Georgia, United States
- Norcross, Georgia, United States
- Willowbrook, Illinois, United States
- Iowa City, Iowa, United States
- Great Falls, Montana, United States
- Charlotte, North Carolina, United States
- Statesville, North Carolina, United States
- Charleston, South Carolina, United States
+ 29 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tuscaloosa, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Chula Vista, California, United States; Covina, California, United States; Los Alamitos, California, United States and 43 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.