Progressive Multifocal Leukoencephalopathy study: 89 Zr-Df-crefmirlimab
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?
an investigational radioactive tracer being studied to help PET scans detect immune cells in the brain of people with progressive multifocal leukoencephalopathy and related conditions is designed to bind CD8 glycoprotein on immune cells and carry a Zr-89 label so the cells can be visualized with PET imaging
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
- The study wants to find out if a special PET scan tracer can show certain immune cells in the central nervous system of people with multiple sclerosis, progressive multifocal leukoencephalopathy, or related neuroinflammatory conditions.
- Who it's for
- Adults 18 years or older who have MS, PML, or another neuroinflammatory disease that leaks across the blood‑brain barrier.
- What's involved
- You will receive a short IV infusion of the tracer, have physical and neurological exams, blood and heart tests, an MRI of the brain, and possibly a spinal tap. You will undergo one or two PET scans, each lasting about an hour.
- Time commitment
- The study lasts 4–6 weeks with at least three clinic visits, plus an optional repeat scan for PML participants within six months.
- 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).
You likely can't join if
- 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...
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.
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.