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New treatment option for Progressive Multifocal Leukoencephalopathy
Official title Central Nervous System Uptake of Anti-CD8+ T Cell Minibodies in Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy
ClinicalTrials.gov ID: NCT05849467
What this study is testing
What is 89 Zr-Df-crefmirlimab?
89 Zr-Df-crefmirlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for progressive multifocal leukoencephalopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria: Multiple Sclerosis Enrolled in the NINDS...
- 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). PML Enrolled...
You likely can't join if
- 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.
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria: Multiple Sclerosis 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). PML 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. Patients with Known or Suspected Neuroinflammatory Diseases and Evidence of Open...
- Recent brain MRI (within 1 month) with gadolinium enhancement indicating open BBB.
- 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.
- 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) OR AST greater than 1.5 x ULN OR ALT greater than 1.5 x ULN.
- Has a total bilirubin \>1.5X ULN, unless known to have elevated bilirubin due to nonliver related disorder or Gilbert s.
- Creatinine clearance \< 60 mL/min as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
- For females of reproductive potential: inability to use highly effective contraception for at least one month prior to screening and during study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.