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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits
  • Procedures mentioned: Blood draws, MRI scans, Spinal tap (lumbar puncture), PET scans, Infusions, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Design: Participants will come to the clinic for at least 3 visits over 4 to 6 weeks."
  • "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."
  • "Participants may have a PET scan on the day of the Minibody and will return the next day for another PET scan."
  • "Participants with PML may opt to repeat the minibody infusion and the PET scan within 6 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether an experimental radioactive tracer can help PET scans find certain immune cells in the brain, spinal cord, and nerves used for sight. It is for adults with multiple sclerosis (MS), progressive multifocal leukoencephalopathy (PML), or certain other diseases that cause swelling in these areas.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Be able to understand and sign a form agreeing to join the study.
  • Be willing to follow all study steps and stay in the study until it ends.
  • For the MS group: have MS that meets the study’s diagnosis rules and be enrolled in the NINDS Natural History Study for MS.
  • For the PML group: have confirmed PML, or PML-IRIS, an immune reaction linked to PML. Be enrolled in the NINDS Natural History Study for PML.
  • For the other disease group: have a known or suspected disease causing swelling in the brain, spinal cord, or nerves used for sight, other than MS or PML.
  • For the other disease group: have a brain MRI from the past month showing a leak in the blood-brain barrier, which normally limits what passes from blood into the brain.

Who can't join

  • Be pregnant or breastfeeding.
  • Be unable to safely have the study’s MRI scan or gadolinium, the dye used for MRI.
  • Have another past or current health condition that would make taking part unsafe or difficult.
  • Weigh more than 350 pounds (158 kg), or be unable to fit in the MRI or PET scanner.
  • Have a strong fear of small spaces that does not improve with medicine taken by mouth.
  • Have blood tests above the study’s limits: alkaline phosphatase over twice normal, or AST, ALT, or bilirubin over 1.5 times normal. Some exceptions apply for alkaline phosphatase or bilirubin changes not caused by liver disease.
  • Have a kidney filtering rate below 60 mL/min.
  • If able to become pregnant: be unable to use highly effective birth control for at least one month before screening and throughout the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

MD