RecruitingPhase 1NCT05849467

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


Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Enrollment

15 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special type of molecular imaging can detect immune T-cells (a type of immune cell) inside the brain and spinal cord of people with multiple sclerosis (MS) or a related brain infection called progressive multifocal leukoencephalopathy (PML). Understanding where and how many T-cells are present may help with diagnosis and treatment. **You may be eligible if...** - You have a confirmed diagnosis of multiple sclerosis (already enrolled in an NIH natural history study for MS) - OR you have progressive multifocal leukoencephalopathy (PML), a rare brain infection - You are willing to undergo imaging and study procedures - Healthy volunteers without neurological conditions may also be eligible as comparison participants **You may NOT be eligible if...** - You are unable to undergo brain imaging (e.g., claustrophobia, metal implants, or pacemaker) - You are pregnant or breastfeeding - You have a serious unrelated medical condition - You are unwilling or unable to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG89 Zr-Df-crefmirlimab

an 80 kDa minibody (Mb) with high affinity to CD8 glycoprotein (binding EC50 = 0.4 nM) that is conjugated with deferoxamine (Df) and radiolabeled with the positron emitting radionuclide, Zr-89 (T1/2 78.4 hours).


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05849467


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