RECRUITING Phase 2 ClinicalTrials.gov

T-cell Therapy in Patients With PML

Sponsor: Hannover Medical School • ClinicalTrials.gov ID: NCT06990087

Registry updated: 2026-10-15

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Description

There is no approved standard treatment für progressive multifocal leukoencephalopathy (PML). The sponsor of the study is developing a new treatment. For this reason, the investigational medicinal product (IMP) called 'human allogenic HPyV-2-specific T cells' is to be tested in this study. The sponsor wants to find out whether the IMP is safe, influences the neurological status and improves the quality of the life of patients . It is to be investigated whether the IMP can be used to treat the disease and whether it could have an advantage over the standard therapy in terms of survival rate.

Interventions

Application of T-lymphocytes (Drug)
Dosage form: Infusion; Route of administration: Intravenous; Cell dose: 1-2 x 10.000 viable CD3+ T-lymphocytes per kg bodyweight; Application at three timepoints: baseline, after two weeks, after 6 weeks

Eligibility criteria

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)

Conditions

Progressive Multifocal Leucoencephalopathy (PML)

Locations

LMU Klinikum Campus Großhadern — München, Bavaria, Germany
Universitätsklinikum Marburg — Marburg, Hesse, Germany
Hannover Medical School — Hanover, Lower Saxony, Germany
Universitätsklinikum Bonn — Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany
Universitätsklinikum Essen — Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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