T-cell Therapy in Patients With PML
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
| Condition(s) | Progressive Multifocal Leucoencephalopathy (PML) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 * Pre |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Hannover Medical School |
| Locations | München, Bavaria, Germany; Marburg, Hesse, Germany; Hanover, Lower Saxony, Germany; Düsseldorf, North Rhine-Westphalia, Germany; Essen, North Rhine-Westphalia, Germany; Kiel, Schleswig-Holstein, Germany |
| Start date | 2026-02-06 |
| NCT ID | NCT06990087 |
| Official listing | https://clinicaltrials.gov/study/NCT06990087 |