Experimental T-Cell therapy takes on deadly brain virus
NCT ID NCT06990087
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment for progressive multifocal leukoencephalopathy (PML), a rare brain infection with no approved therapy. Researchers will give 23 patients donor immune cells that target the virus causing PML. The goal is to see if the treatment is safe, improves neurological function, and helps patients live longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- allogeneic HPyV-2-specific T-cells (donor immune cells targeting the virus)
- What this could lead to
- If successful, this could provide a new treatment option for PML, a rare and often fatal brain infection, potentially improving survival and quality of life.
- What could go wrong
- This is an early Phase 2 trial with only 23 participants, so results may not apply to all PML patients. There are risks of immune reactions like graft-versus-host disease or allergic responses.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 23 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults\* aged ≥ 18 years with PML (diagnosed ≤ 60 days before screening) associated with one or more of the following risk factors: lymphoproliferative diseases, immunosuppressive therapy, or lymphopenia * Signed written informed consent from subject and/or legal representative * HPyV-2 detection in CSF by PCR analysis or in brain biopsy Exclusion Criteria: * PML caused by HIV * PML caused by natalizumab * PML occurring within five 5 years after hematopoietic stem-cell transplantation or CAR T cell therapy, or resulting from chronic lymphocytic leukemia (CLL) * Patients who are unable to follow the study protocol, either on their own or with the support of a reliable representative, will be excluded * Pregnancy or breastfeeding * Currently receiving chemotherapy * Present (within 2 weeks before screening visit) and continuous treatment with immune checkpoint inhibition therapy * Severe infections other than PML (e.g. sepsis, pneumonia) * Hypersensitivity to any of the components of the medications used * Inability to undergo MRI examination (e.g. implanted incompatible medical devices, claustrophobia) * Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hannover Medical School
RECRUITINGHanover, Lower Saxony, 30625, Germany
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LMU Klinikum Campus Großhadern
NOT_YET_RECRUITINGMünchen, Bavaria, 81377, Germany
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Universitätsklinikum Düsseldorf
NOT_YET_RECRUITINGDüsseldorf, North Rhine-Westphalia, 40225, Germany
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Universitätsklinikum Essen
NOT_YET_RECRUITINGEssen, North Rhine-Westphalia, 45147, Germany
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Universitätsklinikum Marburg
NOT_YET_RECRUITINGMarburg, Hesse, Germany
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Universitätsklinikum Schleswig-Holstein
NOT_YET_RECRUITINGKiel, Schleswig-Holstein, 24105, Germany