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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 127 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv127
  2. Primary completion pushed from Feb 1, 2027 to Apr 1, 2030 Completion pushed from Feb 1, 2027 to Dec 1, 2030v126 Show 1 more changeShow less
    • Completion pushed from Feb 1, 2027 to Dec 1, 2030
  3. Primary and study completion pushed from Jun 30, 2026 to Feb 1, 2027v125
  4. 2 versions Re-verified since Mar 2, 2026, no change to tracked fieldsv123-v124
  5. Eligibility criteria revisedv122 See this version in full on ClinicalTrials.gov ↗
Show 44 earlier versionsHide 44 earlier versions
  1. Eligibility criteria expanded, about 22 wordsv121 See this version in full on ClinicalTrials.gov ↗
  2. 4 versions Re-verified since Sep 11, 2025, no change to tracked fieldsv117-v120
  3. Secondary endpoints: 2 to 3 Study arms: 2 to 3v116 Show 1 more changeShow less
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  4. Eligibility criteria expanded, about 26 words Study description expanded, about 38 wordsv115 Show 1 more changeShow less
    • Study description expanded, about 38 words

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 10 to 15v114
  6. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2026v113
  7. 4 versions Re-verified since Jul 25, 2024, no change to tracked fieldsv109-v112
  8. Primary and study completion dates: Jun 30, 2024 to Jun 30, 2025v108
  9. 2 versions Re-verified since Mar 26, 2024, no change to tracked fieldsv106-v107
  10. Eligibility criteria expanded, about 90 wordsv105 See this version in full on ClinicalTrials.gov ↗
  11. 3 versions Re-verified since Dec 1, 2023, no change to tracked fieldsv102-v104
  12. Start date changed from estimate of Oct 26, 2023 to Oct 19, 2023v101
  13. Start date: Oct 25, 2023 to Oct 26, 2023v100
  14. Start date: Oct 24, 2023 to Oct 25, 2023v99
  15. Trial status: Not Yet Recruiting to Recruiting Start date: Oct 23, 2023 to Oct 24, 2023 · Site details revisedv98 Show 2 more changesShow less
    • Start date: Oct 23, 2023 to Oct 24, 2023
    • Site details revised
  16. Start date: Oct 22, 2023 to Oct 23, 2023v97
  17. Start date: Oct 19, 2023 to Oct 22, 2023v96
  18. Start date: Oct 17, 2023 to Oct 19, 2023v95
  19. Start date: Oct 16, 2023 to Oct 17, 2023v94
  20. Start date: Oct 15, 2023 to Oct 16, 2023v93
  21. Start date: Oct 12, 2023 to Oct 15, 2023v92
  22. Start date: Oct 11, 2023 to Oct 12, 2023v91
  23. Start date: Oct 10, 2023 to Oct 11, 2023v90
  24. Start date: Oct 9, 2023 to Oct 10, 2023v89
  25. Start date: Oct 8, 2023 to Oct 9, 2023v88
  26. Start date: Oct 5, 2023 to Oct 8, 2023v87
  27. Start date: Oct 4, 2023 to Oct 5, 2023v86
  28. Start date: Oct 2, 2023 to Oct 4, 2023v85
  29. Start date: Oct 1, 2023 to Oct 2, 2023v84
  30. Start date: Sep 28, 2023 to Oct 1, 2023v83
  31. Start date: Sep 26, 2023 to Sep 28, 2023v82
  32. Start date: Sep 21, 2023 to Sep 26, 2023v81
  33. Start date: Sep 20, 2023 to Sep 21, 2023v80
  34. Start date: Sep 19, 2023 to Sep 20, 2023v79
  35. Start date: Sep 18, 2023 to Sep 19, 2023v78
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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, other neuroinflammatory diseases with BBB leakage, 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 may have a PET scan on the day of the Minibody and will return the next day for another 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.
Trial Details
NCT Number NCT05849467
Lead Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Progressive Multifocal Leukoencephalopathy, Multiple Sclerosis, Other Neuroinflammatory Diseases With BBB Leakage
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov