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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 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.
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. ...
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02694783
The ClinicalTrials.gov registry entry for NCT02694783 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PyVST is the first listed.
NCT02694783 reports 0 study locations.
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.
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