Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Multicenter, Phase Ib/IIa Study on the Safety and Efficacy of Autologous Peptide-coupled Red Blood Cells in Patients with Relapsing Remitting Multiple Sclerosis

This research is looking into a new treatment for people with Relapsing Remitting Multiple Sclerosis (RRMS). The treatment involves using your own red blood cells, which are then specially changed and put back into your body. This early-stage study, called Phase I/IIa, primarily aims to check how safe this new treatment is and if your body tolerates it well. Doctors will be watching closely for any side effects and seeing if the treatment helps to reduce MS relapses or new changes in the brain that show up on MRI scans. They will also look at whether your immune system's response to your own body changes. This is important foundational research to understand if this new approach could be a helpful option for people with RRMS in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Cellerys AG

Enrolment target

Start

19 Sep 2024

Relapsing Remitting Multiple Sclerosis (RRMS)

What is this study about?

This study is investigating a new and different approach to treating Relapsing Remitting Multiple Sclerosis (RRMS). RRMS is a condition where the body's immune system mistakenly attacks its own healthy tissues, particularly in the brain and spinal cord, leading to periods of new or worsening symptoms called relapses.

The experimental treatment in this study uses your own red blood cells. These cells are taken from your body, specially prepared by connecting them with certain 'peptides' (small protein pieces), and then put back into your body. The idea is to teach your immune system to be less aggressive towards its own tissues, potentially reducing relapses and changes in the brain that are seen on MRI scans. This is an early-stage study, meaning it's one of the first times this specific treatment has been tested in people.

The main goal of this particular study is to carefully check if this new treatment is safe and if people can tolerate it without too many problems. The researchers will be closely monitoring for any side effects. They will also be looking to see if the treatment has any positive effects, such as reducing the number of MS relapses or preventing new areas of damage in the brain. They will use detailed MRI scans and other tests to keep track of these changes, with expert doctors reviewing the scans independently.

Key takeaways

This study is testing a new MS treatment using your own red blood cells.
The main goal is to check how safe the treatment is.
It's an early-stage study for Relapsing Remitting MS (RRMS).
Doctors will watch for side effects and disease changes using MRI scans.
You need to be 18 or older with RRMS to be considered.
Participation involves clinic visits, blood tests, and MRI scans.

Who may be eligible?

To be considered for this study, you need to have a diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).

If you are 18 years old or older, you might be able to participate. There isn't an upper age limit mentioned, so adults of all ages, beyond 18, could potentially take part.

Both men and women are welcome to participate in this research. The study aims to include a diverse group of people with RRMS to understand how the treatment works across different individuals.

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.

I am 18 years old or older.
I have been diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS).
I can attend regular clinic appointments and MRI scans.
I understand this is an early-stage study for a new treatment.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to make sure you're a good fit. This will involve various tests and checks. If you're eligible, you'll receive the study treatment, which involves taking your own red blood cells, preparing them, and putting them back into your body. This will happen over several visits to the clinic.

Throughout the study, you'll have regular follow-up appointments. These visits will include physical examinations, blood tests, and detailed brain MRI scans. These tests are important for the doctors to monitor your health, check for any side effects, and see how your MS is responding to the treatment. You will also complete questionnaires about your symptoms and how you're feeling. The total time you'd be involved in the study would depend on the full study plan, which the research team would explain in detail.

Potential risks and benefits

Participating in a clinical trial offers the chance to access a new, experimental treatment for your MS before it’s widely available. While the main focus of this early-stage study is to understand safety, there's a possibility the treatment might help reduce your MS symptoms or limit disease progression. However, like any new treatment, there are potential risks, including side effects from the treatment or the procedures involved, and the treatment might not be effective for you. You will be closely monitored for any problems. It's very important to remember that joining this study is entirely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Germany
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Unverified
Czechia

Common questions

What is Relapsing Remitting Multiple Sclerosis (RRMS)?

It's a type of MS where you have periods of new or worsening symptoms (relapses) followed by periods of recovery.

What does 'autologous' mean in this study?

It means the treatment uses your own red blood cells, rather than cells from someone else.

What is a 'Phase Ib/IIa study'?

This is an early stage of clinical research. Phase I studies mostly check if a new treatment is safe, while Phase II studies start to look at whether it works and find the right dose.

Will I know if I'm getting the active treatment?

In some studies, participants might not know if they are getting the new treatment or a placebo. The study team will explain the details of this to you before you agree to participate.

What are 'MRI brain lesions'?

These are areas of damage in your brain that can be seen on a special scan called an MRI, often linked to MS activity.