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New treatment option for Progressive Multifocal Leucoencephalopathy (PML)
Official title T-cell Therapy in Patients With PML
ClinicalTrials.gov ID: NCT06990087
What this study is testing
What is Application of T-lymphocytes?
Application of T-lymphocytes is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for progressive multifocal leucoencephalopathy (pml).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- There is no approved standard treatment für progressive multifocal leukoencephalopathy (PML). The sponsor of the study is developing a new treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults\ aged ≥ 18 years with PML (diagnosed ≤ 60 days before screening) associated with one or more of the following risk factors...
- Signed written informed consent from subject and/or legal representative
- HPyV-2 detection in CSF by PCR analysis or in brain biopsy
You likely can't join 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...
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- München, Bavaria, Germany
- Marburg, Hesse, Germany
- Hanover, Lower Saxony, Germany
- Düsseldorf, North Rhine-Westphalia, Germany
- Essen, North Rhine-Westphalia, Germany
- Kiel, Schleswig-Holstein, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include München, Bavaria, Germany; Marburg, Hesse, Germany; Hanover, Lower Saxony, Germany; Düsseldorf, North Rhine-Westphalia, Germany; Essen, North Rhine-Westphalia, Germany; Kiel, Schleswig-Holstein, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.