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Radioactive Tracer for Multiple Sclerosis

Phase 1

Recruiting

Led By Daniel S Reich, M.D.

Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after first pet/ct scan

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether a radioactive tracer (minibody) can help identify certain immune cells in people w/ MS & PML. Eligible participants aged 18+ must come to clinic for 3 visits over 4-6 weeks for physical & neurological exams, MRI, & PET scan.

Who is the study for?

Adults aged 18+ with Multiple Sclerosis or Progressive Multifocal Leukoencephalopathy can join. They must be part of existing NINDS studies, understand and agree to the study's consent form, follow all procedures, and women must use effective contraception. Excluded are pregnant or breastfeeding individuals, those who can't have MRI contrast or fit in scanners, and anyone with conditions that could affect their participation.

What is being tested?

The trial is testing a radioactive tracer called minibody (89 Zr-Df-crefmirlimab) used during PET scans to detect immune cells in the CNS of MS and PML patients. Participants will receive an infusion of minibody followed by PET scans over several visits spanning 4-6 weeks.

What are the potential side effects?

Potential side effects aren't detailed but may include reactions related to the infusion process such as discomfort at injection site or allergic reactions, plus any risks associated with exposure to radiation from the tracer used in PET scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months after first pet/ct scan

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months after first pet/ct scan

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after first pet/ct scan for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Infiltration of CD8+ T cells in the CNS of adults with MS and PML via PET-CT scans using a minibody with high affinity for CD8+ T cells.

Secondary study objectives

For the PML cohort with longitudinal evaluation, effects of immune reconstitution, either spontaneous or facilitated, on 89Zr-Dfcrefmirlimab uptake.

Safety of 89Zr-Dfcrefmirlimab in the participants with CNS disease.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Progressive Multifocal LeukoencephalopathyExperimental Treatment1 Intervention

PML cohort- Up to five study visits. (1) Baseline; (2) Day 0: MRI brain (with gadolinium) followed by an intravenous injection of anti-CD8 minibody (aka "PET/CT tracer"); (3) Day 1: PET/CT scan; (4) Study visit 4 (optional; time-period between study visit 3 and 4 is variable): MRI brain (with gadolinium) followed by an intravenous injection of anti-CD8 minibody (aka "PET/CT tracer") following clinical, radiological and/or laboratory-defined immune reconstitution (spontaneous or facilitated); (5) Study visit 5: PET/ CT scan

Group II: Multiple SclerosisExperimental Treatment1 Intervention

MS cohort- Three study visits. (1) Baseline; (2) Day 0: MRI brain/spinal cord (with gadolinium) followed by an intravenous injection of anti-CD8 minibody (aka"PET/CT tracer"); (3) Day 1: PET/CT scan

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