Status:
NOT_YET_RECRUITING
T-cell Therapy in Patients With PML
Lead Sponsor:
Hannover Medical School
Conditions:
Progressive Multifocal Leucoencephalopathy (PML)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pro...
Detailed Description
Progressive multifocal leukoencephalopathy (PML) is a severe infection of the central nervous system (CNS) caused by reactivation of human polyoma virus 2 (HPyV-2). HPyV-2 usually produces asymptomati...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06990087
Start Date
November 1 2025
End Date
November 1 2027
Last Update
November 24 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.