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NCT02694783 · ClinicalTrials.gov registry record · Early Phase 1
Adoptive Cellular Immunotherapy for Progressive Multifocal Leukoencephalopathy With Ex Vivo Generated Polyomavirus-Specific T-Cells
A Early Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
NCT02694783: Completed Early Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT02694783 is a Early Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 60 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02694783, a Early Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
Background: Progressive Multifocal Leukoencephalopathy (PML) is a brain infection in people with a weakened immune system. Researchers think polyoma virus specific T cells (PyVST) therapy can treat PML. The PyVST cells are made from blood cells of a healthy relative. They are grown in a lab to expand the virus-killing cells, then given to the person with PML. Objective: To test whether PyVST safely treats PML. Eligibility: * Adults ages 18 and older with PML * Healthy adults ages 18 and older who have: * Been screened under protocol 97-H-0041 * A sibling, parent, or child with PML and matching cells Design: * Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * PML participants will also be screened with: * Cerebrospinal fluid removed by needle in the back. * MRI: A dye is injected in a vein. They lie on a table that slides into a cylinder. * Questionnaires Healthy participants will have apheresis: Blood flows through a needle in one arm into machine that separates blood cells needed for donation. The rest of the blood is returned by needle to the other arm. Some participants may have a central line placed in a vein instead. They can have apheresis up to 3 times, at least 28 days apart. Participants with PML will receive the PyVST cells by needle in the arm. They will stay in the hospital 1 week. They can do this up to 3 times, at least 28 days apart. After each infusion, they will have weekly visits for 1 month. Then they will have 4 visits over 1 year. Visits include repeats of screening tests. ...
Primary Outcome
Characterization of the safety and feasibility of PyVST infusion for the treatment of PML based on development of Treatment Limiting Toxicity
Interventions
- BIOLOGICAL PyVST
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2016-03-28 |
| Est. Completion | 2020-03-06 |
| Phase | Early Phase 1 |
What the finished NCT02694783 record still lists
NCT02694783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 1 intervention - of which PyVST is the first listed.
NCT02694783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02694783 about?
NCT02694783 is a clinical study titled "Adoptive Cellular Immunotherapy for Progressive Multifocal Leukoencephalopathy With Ex Vivo Generated Polyomavirus-Specific T-Cells". Background: Progressive Multifocal Leukoencephalopathy (PML) is a brain infection in people with a weakened immune system. Researchers think polyoma virus specific T cells (PyVST) therapy can treat PML. The PyVST cells are made from blood cells of a healthy relative. They are grown in a lab to expa...
What is the current status of trial NCT02694783?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2016-03-28. Estimated completion is 2020-03-06.
What interventions are being tested in trial NCT02694783?
The interventions under investigation include: PyVST (BIOLOGICAL).
Who is sponsoring clinical trial NCT02694783?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02694783's enrollment target sits among peer trials
60 403rd of 2000 higher than 1,565 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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