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

Launched by NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) · May 8, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new method to help doctors see certain immune cells in the brains of people with multiple sclerosis (MS) and progressive multifocal leukoencephalopathy (PML) using a special imaging technique called positron emission tomography (PET) scans. The researchers want to find out if a small radioactive substance, called a minibody, can improve the way these scans work. This is important because both MS and PML can damage the central nervous system, which includes the brain and spinal cord, leading to various symptoms like muscle weakness and problems with vision and coordination.

To participate in this study, individuals must be 18 years or older and have a diagnosis of MS or PML. They will need to visit the clinic several times over a month or so for physical exams, blood tests, and brain imaging. Participants will receive the minibody through a small needle in their arm, which takes just a few minutes. The following day, they will have a PET scan that lasts about an hour. For those with PML, there is an opportunity to repeat the process within six months if they choose. Overall, this trial aims to enhance our understanding of these conditions and improve future treatments.

Gender

ALL

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).
• • For females of reproductive potential: agrees to use highly effective contraception for at least one month prior to screening and during study participation.
• • Creatinine clearance \>= 60 mL/min as estimated by the Cockcroft-Gault equation.
• • Has aspartate transaminase (AST) or alanine transaminase (ALT) levels less than 1.5x ULN.
• • 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.
• • For females of reproductive potential: agrees to use highly effective contraception for at least one month prior to screening and during study participation.
• • Creatinine clearance \>= 60 mL/min as estimated by the Cockcroft-Gault equation.
• • Has aspartate transaminase (AST) or alanine transaminase (ALT) levels less than 1.5x ULN.
• 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, and AST and ALT remain stable.
• • Has a total bilirubin \>1.5X ULN, unless known to have elevated bilirubin due to nonliver related disorder or Gilbert s.