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Adoptive Cellular Immunotherapy for Progressive Multifocal Leukoencephalopathy With Ex Vivo Generated Polyomavirus-Specific T-Cells

NCT02694783 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-01

No results posted yet for this 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.

Conditions

  • Progressive Multifocal Leukoencephalopathy

Interventions

BIOLOGICAL

PyVST

ex vivo generated polyomavirus-specific T cells from HLA-matched donor

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Irene CM Cortese, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-28
Primary Completion
2019-12-13
Completion
2020-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02694783 on ClinicalTrials.gov