Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06990087

T-cell Therapy in Patients With PML

Led by Hannover Medical School · Updated on 2026-02-12

23

Participants Needed

6

Research Sites

90 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

T-cell Therapy in Patients With PML

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older with PML diagnosed within 60 days before screening and associated with lymphoproliferative diseases, immunosuppressive therapy, or lymphopenia
  • Signed written informed consent from the participant or legal representative
  • Detection of HPyV-2 in cerebrospinal fluid by PCR or in brain biopsy
Not Eligible

You will not qualify if you...

  • PML caused by HIV or natalizumab
  • PML occurring within 5 years after hematopoietic stem-cell transplantation or CAR T cell therapy, or resulting from chronic lymphocytic leukemia (CLL)
  • Inability to follow the study protocol independently or with support
  • Pregnancy or breastfeeding
  • Current chemotherapy treatment
  • Treatment with immune checkpoint inhibition therapy within 2 weeks before screening
  • Severe infections other than PML (e.g., sepsis, pneumonia)
  • Hypersensitivity to any medication components used in the study
  • Inability to undergo MRI examination (e.g., incompatible implants, claustrophobia)
  • Participation in another clinical trial with investigational drugs or devices within 30 days prior to enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

LMU Klinikum Campus Großhadern

München, Bavaria, Germany, 81377

Not Yet Recruiting

2

Universitätsklinikum Marburg

Marburg, Hesse, Germany

Not Yet Recruiting

3

Hannover Medical School

Hanover, Lower Saxony, Germany, 30625

Actively Recruiting

4

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany, 40225

Not Yet Recruiting

5

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany, 45147

Not Yet Recruiting

6

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany, 24105

Not Yet Recruiting

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Research Team

T

Thomas Skripuletz, Prof. Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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