Using a radioactive tracer to detect immune cells in the brain for multiple sclerosis and PML
Central Nervous System Uptake of Anti-CD8+ T Cell Minibodies in Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy: A Pilot Study
This study is testing a new radioactive tracer to see if it can help find certain immune cells in the brains of people with multiple sclerosis and PML.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | crefmirlimab, Dfcrefmirlimab |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05849467 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an experimental radioactive tracer, known as a minibody, in detecting CD8+ T lymphocytes in the central nervous system of patients with multiple sclerosis (MS) and progressive multifocal leukoencephalopathy (PML) using positron emission tomography (PET) scans. Participants aged 18 and older will undergo a series of tests, including physical exams, blood tests, MRI scans, and possibly spinal taps over a period of 4 to 6 weeks. The primary goal is to assess the uptake of the tracer in different brain regions, while also monitoring safety and tolerability.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with multiple sclerosis or progressive multifocal leukoencephalopathy.
Not a fit: Patients who do not have MS or PML, or those who are unable to comply with study procedures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the understanding and diagnosis of MS and PML by providing a noninvasive method to visualize immune cell activity in the brain.
How similar studies have performed: While this approach is novel in the context of MS and PML, similar imaging techniques have shown promise in other inflammatory conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Multiple Sclerosis Inclusion Criteria * Enrolled in the NINDS Natural History Study for MS (protocol 89-N-0045) * Able to understand, and willing to sign, a written, informed consent document. * Willing to comply with all study procedures and available for the duration of the study. * Male or female, aged \>=18. * Diagnosis of MS according to the 2017 revision of the McDonald diagnostic criteria48 (in the presence or absence of a clinical relapse). PML Inclusion Criteria * Enrolled in the NINDS Natural History Study for PML (protocol 13-N-0017) * Able to understand and willing to sign a written, informed consent document * Willing to comply with all study procedures and available for the duration of the study. * Male or female, aged \>=18. * Diagnosis of definite PML according to 2013 AAN Consensus Criteria49 or PML-IRIS based on clinical, radiological and laboratory evidence. Patients with Known or Suspected Neuroinflammatory Diseases and Evidence of Open BBB Inclusion Criteria -Clinical evaluation suggesting an inflammatory disorder of the central nervous system other than MS or PML. Other confirmed neuroinflammatory disorders may include -MOGAD, NMOSD, Behcet's syndrome, and neurosarcoidosis. Unconfirmed, though suspected cases of neuroinflammation may also be included. * Recent brain MRI (within 1 month) with gadolinium enhancement indicating open BBB. * Able to understand and willing to sign a written, informed consent document. * Willing to comply with all study procedures and available for the duration of the study. * Male or female, aged \>=18. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Pregnant or lactating. * Contraindications for MRI gadolinium contrast administration or 3T MRI. * History of, or current diagnosis with, concomitant medical or clinical conditions that would adversely affect participation in this study. * Weighs \> 350 lb. (158 kg; weight limit for the scanner table) or is unable to fit within the MRI or PET imaging gantry. * Severe claustrophobia unresponsive to oral anxiolytics. * Has an alkaline phosphatase level greater than 2x ULN (unless known to have non-liver related disorder) OR AST greater than 1.5 x ULN OR ALT greater than 1.5 x ULN. * Has a total bilirubin \>1.5X ULN, unless known to have elevated bilirubin due to nonliver related disorder or Gilbert s. * Creatinine clearance \< 60 mL/min as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) * For females of reproductive potential: inability to use highly effective contraception for at least one month prior to screening and during study participation.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Daniel S Reich, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
- Study coordinator: Maria I Gaitan, M.D.
- Email: maria.gaitan@nih.gov
- Phone: (301) 496-1801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.