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New treatment option for Refractory Rheumatoid Arthritis (RA)
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 Allogeneic NK Cells?
Allogeneic NK Cells is an investigational medicine, being studied as a potential treatment for refractory rheumatoid arthritis (ra).
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
- 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.
- 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
- For people 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...
See the full eligibility criteria
- For people 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 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's taking place
- 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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.