T-cell Therapy in Patients With PML
Recruiting now · Phase 2
Conditions studied: Progressive Multifocal Leucoencephalopathy (PML)
In brief
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.
Key facts
- Study ID
- NCT06990087
- Run by
- Hannover Medical School
- People needed
- 23
- Starts
- 2026-02-06
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Hannover Medical School — Hanover, Lower Saxony, Germany (enrolling)
- LMU Klinikum Campus Großhadern — München, Bavaria, Germany
- Universitätsklinikum Marburg — Marburg, Hesse, Germany
- Universitätsklinikum Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany
- Universitätsklinikum Essen — Essen, North Rhine-Westphalia, Germany
- Universitätsklinikum Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany
Full record on ClinicalTrials.gov
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