NCT06990087

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
18mo left

Started Feb 2026

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Feb 2026Nov 2027

First Submitted

Initial submission to the registry

April 29, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

February 6, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

April 29, 2025

Last Update Submit

February 10, 2026

Conditions

Progressive Multifocal Leucoencephalopathy (PML)

Outcome Measures

Primary Outcomes (1)

  • Demonstrate efficacy of treatment

    Determine proportion of patients surviving 6 months (overall survival) since diagnosis.

    6 months after diagnosis

Secondary Outcomes (21)

  • Safety assessment

    During 12 months from baseline

  • Safety assessment

    At 12 months from baseline

  • Assessment of potential inflammatory safety concerns

    During 6 months from baseline

  • Assessment of potential inflammatory safety concerns

    During 6 months from baseline

  • Assessment of potential inflammatory safety concerns

    During 6 months from baseline

  • +16 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Study participants receive complete or partially HLA-matched, allogeneic HPyV-2-specific T-lymphocytes

Drug: Application of T-lymphocytes

Interventions

Application of T-lymphocytesDRUG

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

LMU Klinikum Campus Großhadern

München, Bavaria, 81377, Germany

NOT YET RECRUITING

Universitätsklinikum Marburg

Marburg, Hesse, Germany

NOT YET RECRUITING

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

NOT YET RECRUITING

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

NOT YET RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Leukoencephalopathy, Progressive Multifocal

Condition Hierarchy (Ancestors)

Encephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisVirus DiseasesPolyomavirus InfectionsDNA Virus InfectionsSlow Virus DiseasesEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesLeukoencephalopathiesDemyelinating DiseasesNeuroinflammatory Diseases

Central Study Contacts

Thomas Skripuletz, Prof. Dr.

CONTACT

+49 511 532skripuletz.thomas@mh-hannover.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 25, 2025

Study Start

February 6, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations

DE(6)