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RecruitingPhase 2NCT06990087

T-cell Therapy in Patients With PML

CurePML - Allogeneic HPyV-2-specific T-cell Therapy in Patients With Progressive Multifocal Leukoencephalopathy

Sponsor

Hannover Medical School

Enrollment

23 participants

Start Date

Feb 6, 2026

Study Type

INTERVENTIONAL

Conditions

Progressive Multifocal Leucoencephalopathy (PML)

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria11

  • 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)

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Interventions

DRUGApplication 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

Locations(6)

LMU Klinikum Campus Großhadern

München, Bavaria, Germany

Universitätsklinikum Marburg

Marburg, Hesse, Germany

Hannover Medical School

Hanover, Lower Saxony, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

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NCT06990087