RecruitingPHASE2INTERVENTIONAL

T-cell Therapy in Patients With PML

This study is investigating a new treatment for Progressive Multifocal Leukoencephalopathy (PML), a rare but serious brain infection. Currently, there's no approved standard treatment. The drug being tested is a special type of immune cell called 'human allogenic HPyV-2-specific T cells'. Researchers want to find out if this T-cell therapy is safe for patients, if it can help improve their brain function, and if it leads to a better quality of life. The study will also look at whether this new treatment could help patients live longer compared to current approaches. This is the first controlled study of its kind for PML using this specific cell therapy.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Hannover Medical School

Enrolment target

Start

06 Feb 2026

Estimated completion

01 Nov 2027

Progressive Multifocal Leucoencephalopathy (PML)

What is this study about?

Progressive Multifocal Leukoencephalopathy (PML) is a very serious infection that affects the brain and spinal cord, which are parts of your central nervous system. It's caused by a common virus called HPyV-2 (sometimes called JC virus), which most people carry without any problems. However, if your immune system becomes very weak, this virus can reactivate and cause PML. Unfortunately, PML is often fatal or leads to severe long-term disability, and there isn't a widely approved treatment for it yet.

This study is looking into a brand new approach using a type of treatment called T-cell therapy. T-cells are a vital part of your immune system that fight off infections. In this study, doctors are using specially prepared T-cells that are designed to target and fight the HPyV-2 virus. They want to see if giving these specific T-cells can help patients combat the infection in their brain.

The main goals of this study are to determine if this new T-cell therapy is safe for people with PML. Researchers will also be checking if it helps improve a patient's neurological status (how well their brain and nervous system are working) and whether it improves their overall quality of life. Because there isn't a standard treatment right now, finding an effective therapy is incredibly important for patients with PML.

Key takeaways

Tests a new T-cell therapy for PML, a severe brain infection.
Aims to check safety, neurological improvement, and quality of life.
PML currently has no approved standard treatment.
Involves special immune cells to fight the HPyV-2 virus.
First controlled trial of this specific T-cell method for PML.

Who may be eligible?

To be considered for this study, you must be at least 18 years old and have been diagnosed with PML within the last 60 days. Your PML must be linked to certain conditions, such as blood cancers (like lymphoproliferative diseases), strong medications that suppress your immune system, or having low levels of key immune cells (lymphopenia). We'll need to confirm the HPyV-2 virus in your spinal fluid or a brain tissue sample.

However, there are reasons why you might not be able to join. For example, if your PML is caused by HIV or a specific medication called natalizumab. Also, if you've had a stem cell transplant or certain advanced cancer therapies (CAR T cell therapy) within the last five years, or have a specific type of blood cancer called chronic lymphocytic leukemia, you wouldn't be eligible. Pregnant or breastfeeding individuals, those currently on chemotherapy or certain immune-blocking drugs, or people with other severe infections cannot participate.

You also need to be able to follow the study instructions, either by yourself or with help from a reliable person. If you can't have an MRI scan (for example, due to certain metallic implants or severe claustrophobia), you wouldn't be able to join. Finally, if you're already taking part in another clinical trial or have done so within the last 30 days, you wouldn't be able to enter this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Was your PML diagnosed within the last 2 months (60 days)?
Is your PML linked to a weak immune system (e.g., certain cancers, strong medications)?
Is your PML *not* caused by HIV or a specific drug called natalizumab?
Are you able to have an MRI scan?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive a course of the new T-cell therapy. This involves an initial dose of fresh T-cells, followed by two more doses of frozen T-cells from the same source. These additional doses would be given two weeks and six weeks after your first dose. Your participation would involve regular check-ups and assessments to monitor your health, how the treatment is affecting you, and your PML symptoms. This will likely include blood tests, neurological exams, and MRI scans of your brain. The total duration of your active involvement in receiving the treatment and being closely monitored would be over a period of at least six weeks, with ongoing follow-up after that to see the longer-term effects of the therapy.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new treatment for PML, a condition with no approved standard cure. We hope this therapy could improve your health and quality of life. However, since this is a new treatment, there could be unknown risks or side effects specific to these T-cells. Common side effects of similar therapies can include fever, chills, and allergic reactions. The study will closely monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

LMU Klinikum Campus Großhadern
Verified postcode
München, Germany· Not yet recruiting
Universitätsklinikum Marburg
Verified postcode
Marburg, Germany· Not yet recruiting
Hannover Medical School
Verified postcode
Hanover, Germany· Recruiting
Universitätsklinikum Düsseldorf
Verified postcode
Düsseldorf, Germany· Not yet recruiting
Universitätsklinikum Essen
Verified postcode
Essen, Germany· Not yet recruiting
Universitätsklinikum Schleswig-Holstein
Verified postcode
Kiel, Germany· Not yet recruiting

Common questions

What is PML?

PML is a serious brain infection caused by a common virus that reactivates when your immune system is very weak.

What is a T-cell therapy?

It's a new type of treatment that uses special immune cells (T-cells) grown in a lab to specifically target and fight the virus causing PML.

Is this a cure for PML?

Researchers are studying if this treatment can help patients, but it's too early to say if it's a cure. This is the first controlled study of its kind.

How long will the treatment last?

You'll receive an initial dose, followed by two more doses at 2 and 6 weeks after that. Monitoring will continue for a longer period.

Can I leave the study if I want to?

Yes, you have the right to withdraw from the study at any time, and it won't affect your regular medical care.

How to find out more

Thomas Skripuletz, Prof. Dr.

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

Always speak to your GP or specialist before deciding to take part in a study.