Actively Recruiting

Phase 1
Age: 18Years - 120Years
All Genders
ID05849467

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

Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-06-05

15

Participants Needed

1

Research Sites

34 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying multiple sclerosis (MS), progressive multifocal leukoencephalopathy (PML), and other neuroinflammatory diseases that affect the central nervous system (CNS), including the brain, spinal cord, and optic nerves. These diseases can cause muscle weakness and problems with vision, speech, and coordination. The study aims to evaluate whether an experimental radioactive tracer called a minibody can help PET scans detect certain immune cells called CD8 plus T cells in the CNS of adults with these conditions. Participants will receive an intravenous injection of the minibody tracer during study visits. The study includes separate groups for MS, PML, and other neuroinflammatory diseases with a breakdown of up to four visits for MS and other diseases, and up to seven visits for PML. Visits involve MRI scans of the brain and spinal cord with contrast, PET/CT scans on consecutive days, and optional additional PET scans. The PML group may have a repeat minibody injection and PET scan within six months to assess changes over time. During the study, participants will undergo physical and neurological exams, blood tests, heart function tests before and after minibody injection, and an MRI brain scan. Some may have a spinal tap to collect spinal fluid. PET scans will take about one hour, with participants lying on a table moving through a scanning machine. Researchers will measure how well the minibody identifies immune cells in different CNS tissues and monitor safety and tolerability. The study will last about 4 to 6 weeks, with some participants possibly followed for up to six months.

CONDITIONS

Brief 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...

  • Male or female aged 18 years or older
  • Diagnosis of multiple sclerosis based on 2017 McDonald criteria
  • Diagnosis of definite PML or PML-IRIS based on clinical, radiological, and laboratory evidence
  • Clinical evaluation suggesting inflammatory CNS disorder with recent brain MRI showing open blood-brain barrier
  • Enrolled in respective NINDS Natural History Study for MS or PML
  • Able and willing to sign informed consent
  • Willing to comply with all study procedures and available for study duration
Not Eligible

You will not qualify if you...

  • Pregnant or lactating individuals
  • Contraindications for MRI gadolinium contrast or 3T MRI
  • Medical or clinical conditions that may affect participation
  • Weight over 350 lb (158 kg) or unable to fit in MRI or PET scanner
  • Severe claustrophobia not responsive to oral anxiolytics
  • Elevated alkaline phosphatase, AST, ALT, or total bilirubin beyond specified limits unless non-liver related
  • Creatinine clearance below 60 mL/min
  • For females of reproductive potential, inability to use highly effective contraception at least one month before and during study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - Up to 1 week

Participants receive an intravenous injection of the anti-CD8 minibody PET tracer and undergo MRI and PET/CT scans to detect CD8+ T cell infiltration in the central nervous system.

2 to 3 visits including MRI and PET/CT scans within 2 days, plus 1 optional PET/CT visit for MS and other neuroinflammatory cohorts; up to 7 visits for the PML cohort including additional MRI and PET/CT scans

Follow-up

Duration - Up to 6 months after first PET/CT scan

Participants in the PML cohort may have additional PET/CT scans and MRI evaluations to monitor longitudinal effects of immune reconstitution on tracer uptake.

Additional visits for optional PET/CT scans and MRI assessments depending on cohort and clinical criteria

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.

D

Daniel S Reich, M.D.

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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