RECRUITING

Central Nervous System Uptake of Anti-CD8+ T Cell Minibodies in Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: Multiple sclerosis (MS) and progressive multifocal leukoencephalopathy (PML) are disorders that affect the central nervous system (CNS). The CNS includes the brain, spinal cord, and optic nerves. Both diseases can cause muscle weakness and impair vision, speech, and coordination. Researchers are working to better understand how MS and PML affect the CNS. Objective: To test whether an experimental radioactive tracer (minibody) can help positron emission tomography (PET) scans detect certain immune cells in the CNS of people with MS and PML. Eligibility: People aged 18 years and older with MS, other neuroinflammatory diseases with BBB leakage, or PML. Design: Participants will come to the clinic for at least 3 visits over 4 to 6 weeks. Participants will undergo testing. They will have a physical and neurological exam. They will have blood tests and tests of their heart function. They will have a magnetic resonance imaging (MRI) scan of the brain. They may have a spinal tap: Their lower back will be numbed, and a needle will be inserted between the bones of the spine to withdraw fluid from around the spinal cord. Minibody is given through a tube with a needle placed in a vein in the arm. This takes 5 to 10 minutes. Participants will have heart function tests before and after receiving the minibody. Participants may have a PET scan on the day of the Minibody and will return the next day for another PET scan. They will lie on a table that moves through a doughnut-shaped machine. This scan will take about 1 hour. Participants with PML may opt to repeat the minibody infusion and the PET scan within 6 months.

Official Title

Central Nervous System Uptake of Anti-CD8+ T Cell Minibodies in Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy: A Pilot Study

Quick Facts

Study Start:2023-10-19
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05849467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Enrolled in the NINDS Natural History Study for MS (protocol 89-N-0045)
  2. * Able to understand, and willing to sign, a written, informed consent document.
  3. * Willing to comply with all study procedures and available for the duration of the study.
  4. * Male or female, aged \>=18.
  5. * Diagnosis of MS according to the 2017 revision of the McDonald diagnostic criteria48 (in the presence or absence of a clinical relapse).
  6. * Enrolled in the NINDS Natural History Study for PML (protocol 13-N-0017)
  7. * Able to understand and willing to sign a written, informed consent document
  8. * Willing to comply with all study procedures and available for the duration of the study.
  9. * Male or female, aged \>=18.
  10. * Diagnosis of definite PML according to 2013 AAN Consensus Criteria49 or PML-IRIS based on clinical, radiological and laboratory evidence.
  11. * Clinical evaluation suggesting an inflammatory disorder of the central nervous system other than MS or PML.
  12. * Recent brain MRI (within 1 month) with gadolinium enhancement indicating open BBB.
  13. * Able to understand and willing to sign a written, informed consent document.
  14. * Willing to comply with all study procedures and available for the duration of the study.
  15. * Male or female, aged \>=18.
  1. * Pregnant or lactating.
  2. * Contraindications for MRI gadolinium contrast administration or 3T MRI.
  3. * History of, or current diagnosis with, concomitant medical or clinical conditions that would adversely affect participation in this study.
  4. * Weighs \> 350 lb (158 kg; weight limit for the scanner table) or is unable to fit within the MRI or PET imaging gantry.
  5. * Severe claustrophobia unresponsive to oral anxiolytics.
  6. * 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.
  7. * Has a total bilirubin \>1.5X ULN, unless known to have elevated bilirubin due to nonliver related disorder or Gilbert s.
  8. * Creatinine clearance \< 60 mL/min as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
  9. * For females of reproductive potential: inability to use highly effective contraception for at least one month prior to screening and during study participation.

Contacts and Locations

Study Contact

Maria I Gaitan, M.D.
CONTACT
(301) 496-1801
maria.gaitan@nih.gov
Daniel S Reich, M.D.
CONTACT
(301) 496-1801
reichds@ninds.nih.gov

Principal Investigator

Daniel S Reich, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

  • Daniel S Reich, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Neurological Disorders and Stroke (NINDS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-19
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-10-19
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • 89 Zr-Df-crefmirlimab
  • PET Imaging

Additional Relevant MeSH Terms

  • Multiple Sclerosis
  • Progressive Multifocal Leukoencephalopathy