Viewing Study NCT05849467



Ignite Creation Date: 2024-05-06 @ 6:57 PM
Last Modification Date: 2024-10-26 @ 2:58 PM
Study NCT ID: NCT05849467
Status: RECRUITING
Last Update Posted: 2024-07-15
First Post: 2023-05-08

Brief Title: Central Nervous System Uptake of Anti-CD8 T Cell Minibodies in Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy
Sponsor: National Institute of Neurological Disorders and Stroke NINDS
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Central Nervous System Uptake of Anti-CD8 T Cell Minibodies in Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy A Pilot Study
Status: RECRUITING
Status Verified Date: 2024-07-22
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 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 will return the next day for the 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
Detailed Description: Study Description

This study will obtain pilot data for noninvasive positron emission tomography PET imaging of CD8 T lymphocytes in two inflammatory central nervous system CNS demyelinating diseases multiple sclerosis MS and progressive multifocal leukoencephalopathy PML by characterizing CNS uptake of anti-CD8 T cell antibody fragment aka minibody 89Zr-Dfcrefmirlimab an investigational intravenous PET tracer

Objectives

Primary Objective To detect and localize infiltration of CD8 T cells in the CNS of adults with MS and PML via PET-CT computed tomography scans using a minibody with high affinity for CD8 T cells

Secondary Objectives 1 To characterize safety and tolerability of 89Zr-Df-crefmirlimab in the participant population 2 For the PML cohort with longitudinal evaluation to determine the effects of immune reconstitution either spontaneous or facilitated on 89Zr-Dfcrefmirlimab uptake

Endpoints

Primary Endpoints Standardized uptake values SUV in different tissue types lesions white matter gray matter meninges choroid plexus as determined from coregistered MRI in each cohort MS or PML by region-of-interest ROI analysis

Secondary Endpoints 1 Frequency and nature of adverse events 2 For the PML cohort with longitudinal evaluation changes in SUV over time

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
001519-N None None None