Actively Recruiting

Phase 1
Age: 18Years - 120Years
All Genders
NCT05849467

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

Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-05-07

15

Participants Needed

1

Research Sites

371 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be male or female aged 18 years or older
  • Able to understand and willing to sign informed consent
  • Willing to comply with all study procedures and available for the duration of the study
  • For Multiple Sclerosis group: diagnosed with MS per 2017 McDonald criteria and enrolled in NINDS Natural History Study for MS
  • For PML group: diagnosed with definite PML or PML-IRIS and enrolled in NINDS Natural History Study for PML
  • For other neuroinflammatory diseases group: clinical evaluation suggesting CNS inflammatory disorder other than MS or PML, including confirmed or suspected cases
  • Recent brain MRI with gadolinium enhancement within 1 month showing open blood-brain barrier
Not Eligible

You will not qualify if you...

  • Pregnant or lactating individuals
  • Contraindications for MRI gadolinium contrast or 3T MRI
  • Medical or clinical conditions adversely affecting study participation
  • Weight over 350 pounds or unable to fit in MRI/PET scanner
  • Severe claustrophobia not responsive to oral anxiolytics
  • Elevated liver enzymes above specified limits unless due to non-liver causes
  • Total bilirubin above 1.5 times upper limit unless due to non-liver causes or Gilbert's syndrome
  • Creatinine clearance below 60 mL/min
  • For females of reproductive potential: inability to use highly effective contraception for at least one month before and during the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

M

Maria I Gaitan, M.D.

CONTACT

D

Daniel S Reich, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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