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Clinical Trials in Germany / NCT06990087
Recruiting Phase 2

T-cell Therapy in Patients With PML

NCT06990087 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2026-02-06
Last updated
2026-02-12

Condition(s) studied

Progressive Multifocal Leucoencephalopathy (PML)

Investigational drug(s) / intervention(s)

Application of T-lymphocytes

Application of T-lymphocytes: 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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
LMU Klinikum Campus Großhadern München Bavaria Not Yet Recruiting
Universitätsklinikum Marburg Marburg Hesse Not Yet Recruiting
Hannover Medical School Hanover Lower Saxony Recruiting
Universitätsklinikum Düsseldorf Düsseldorf North Rhine-Westphalia Not Yet Recruiting
Universitätsklinikum Essen Essen North Rhine-Westphalia Not Yet Recruiting
Universitätsklinikum Schleswig-Holstein Kiel Schleswig-Holstein Not Yet Recruiting

More Hannover Medical School trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06990087 on ClinicalTrials.gov ↗ ← All trials in Germany