AuthorisedTherapeutic exploratory (Phase II)Interventional

An autologous and antigen-specific cell-based therapy of vitamin D3-treated and myelin-derived peptide loaded tolerogenic dendritic cells in subjects with progressive forms of multiple sclerosis: a phase IIa, open-label, self-controlled, multi-center clinical trial.

This study is looking into a new treatment for people with progressive Multiple Sclerosis (MS). The treatment, called tolDC, uses your own immune cells, which are specially prepared to try and calm down the MS. Doctors want to see if this treatment can help reduce the symptoms of MS and slow down how much the disease affects daily life. They will also carefully check for any side effects to make sure the treatment is safe. This is an early-stage study, meaning it’s one of the first times this specific treatment has been tested in people with MS to understand how well it works and if it’s safe.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitair Ziekenhuis Antwerpen, Hospital Germans Trias I Pujol

Enrolment target

Start

20 Apr 2026

Multiple Sclerosis

What is this study about?

This study is about a new way to treat Multiple Sclerosis (MS), specifically for people who have types of MS where symptoms gradually get worse. MS is a condition where your body's immune system, which normally fights off infections, mistakenly attacks the protective coating around your nerves. This can lead to problems with movement, balance, vision, and thinking.

The new treatment being tested is called tolDC. It's a special type of cell therapy that starts by taking some of your own immune cells. These cells are then treated in the lab in a particular way and given back to you. The idea behind tolDC is to 'retrain' your immune system so it stops attacking your nerves, helping to slow down the progression of MS.

The main goal of this study is to find out if tolDC can help improve how you function day-to-day and reduce the impact of MS. Researchers will also be checking very carefully to make sure the treatment is safe and doesn't cause too many side effects. By understanding both the effects and safety, they can decide if this treatment could be a good option for future MS care.

Key takeaways

This study is testing a new cell therapy (tolDC) for progressive MS.
It aims to see if tolDC can reduce MS symptoms and improve daily function.
Safety is a main priority, with careful monitoring for any side effects.
Participants will have regular check-ups, blood tests, and MRI scans.
It's an early-stage study, so results will help us understand the treatment better.

Who may be eligible?

This study is for adults aged 18 and older who have been diagnosed with a progressive form of Multiple Sclerosis. Both men and women can take part.

To be considered, you will need to meet specific health requirements related to your MS and overall health. This includes having a certain level of disability as measured by doctors, and your MS specialist will need to confirm your diagnosis and type of MS.

There will also be certain health conditions or medications that might mean you can't join the study, as they could affect the safety of the treatment or how well it works. These will be discussed in detail by the study team.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of a progressive form of Multiple Sclerosis?
Are you able to attend regular clinic visits and tests?
Are you generally in good health, apart from your MS?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll have regular visits to the clinic over a period of time. During these visits, doctors will monitor your MS symptoms and how you're feeling using special tests. You'll have blood tests to check your overall health and how the treatment is affecting your body. You'll also have brain scans (MRIs) to see any changes in your brain. You will also do specific tasks to check your arm movement and thinking abilities. You'll be asked to complete questionnaires about your pain and general well-being. The study will involve receiving the tolDC treatment and then being followed up for a specific duration to see its long-term effects. The total length of your involvement will be clearly explained by the study team.

Potential risks and benefits

While we hope this new treatment might help improve your MS symptoms or slow down its progression, there's no guarantee it will work for everyone, and it might not work for you. As with any new treatment, there could be side effects. These can range from mild, like feeling tired or having a reaction at the injection site, to more serious effects. The study team will carefully 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 (2)

—
Belgium
—
Spain

Common questions

What is Multiple Sclerosis (MS)?

MS is a condition where your body's immune system mistakenly attacks the protective covering of your nerves, leading to many different symptoms that can affect how you move, see, and think.

What is 'progressive MS'?

Progressive MS means that your symptoms gradually get worse over time, rather than coming and going in 'relapses' like other forms of MS.

What is tolDC?

tolDC is a new type of cell treatment that uses your own immune cells. These cells are specially prepared in the lab to try and 'retrain' your immune system to stop attacking your nerves.

Will I know if I'm getting the treatment?

Yes, this is an 'open-label' study, which means you and your doctors will know if you are receiving the tolDC treatment.

What is an MRI scan?

An MRI is a special type of scan that uses strong magnets and radio waves to create detailed pictures of your brain and spinal cord, helping doctors to see changes related to MS.