T-cell therapy for progressive multifocal leukoencephalopathy (PML).

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial will give adults with recent HPyV-2–positive PML up to three doses of human allogeneic HPyV-2-specific T-lymphocytes (one fresh dose at baseline and two cryopreserved doses at weeks 2 and 6). The donor-derived T-cell apheresis concentrates are targeted to HPyV-2 and are administered to see if they are safe and produce neurologic, quality-of-life, or survival benefits beyond current care. Eligible patients are adults (≥18) with PML diagnosed within 60 days and HPyV-2 detected in CSF or brain biopsy, while several causes of PML (including HIV- and natalizumab-associated cases) and other serious comorbidities are excluded. This is the first controlled trial using this specific T-cell approach and aims to generate standardized safety and early efficacy data beyond small compassionate-use reports under ICH-GCP.

Why it matters

Who can join: the full rules

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)

Where it's running

• LMU Klinikum Campus Großhadern
  München, Bavaria, Germany Recruiting
• Universitätsklinikum Marburg
  Marburg, Hesse, Germany Recruiting
• Hannover Medical School
  Hanover, Lower Saxony, Germany Recruiting
• Universitätsklinikum Bonn
  Bonn, North Rhine-Westphalia, Germany Not yet recruiting
• Universitätsklinikum Düsseldorf
  Düsseldorf, North Rhine-Westphalia, Germany Withdrawn
• Universitätsklinikum Essen
  Essen, North Rhine-Westphalia, Germany Not yet recruiting

Study contacts

• Study coordinator: Thomas Skripuletz, Prof. Dr.
• Email: skripuletz.thomas@mh-hannover.de
• Phone: +49 511 532

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.