Study on the Safety and Effects of YTB323 and Drug Combination in Patients with Progressive Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying the safety and effects of a new treatment for people with Progressive Multiple Sclerosis (PMS), a condition where the immune system mistakenly attacks the protective covering of nerves, leading to worsening symptoms over time. The treatment being tested is called YTB323, which involves using a type of cell therapy. This therapy uses a patient’s own immune cells, which are modified to better target and fight the disease. The study will also involve other medications, including Cyclophosphamide, Tocilizumab, and Fludarabine Phosphate, which are used to prepare the body for the cell therapy.

The purpose of the study is to assess the safety of different doses of YTB323 in patients with PMS. Participants will receive the treatment through an infusion, which is a way of delivering medication directly into the bloodstream. The study will monitor participants over a period of time to observe any changes in their condition and to check for any side effects. This will help researchers understand how the treatment affects the disease and the body.

Throughout the study, participants will undergo various tests and procedures, such as blood tests and MRI scans, to track the progression of the disease and the body’s response to the treatment. The study aims to gather important information that could lead to new treatment options for people living with PMS. The trial is expected to continue for several years to ensure comprehensive data collection and analysis.

1 initial visit

Upon joining the study, you will have an initial visit where you will meet with the study team. During this visit, you will undergo various assessments to ensure you meet the study criteria. These assessments may include a review of your medical history, a physical examination, and tests such as blood draws and brain MRI scans.

2 pre-treatment phase

Before starting the treatment, you will receive two medications: cyclophosphamide and fludarabine phosphate. These medications are given through an intravenous infusion, which means they are delivered directly into your bloodstream through a vein. The purpose of these medications is to prepare your body for the main treatment.

3 main treatment

The main treatment involves the administration of YTB323, which is given through intravenous use. This is the primary medication being studied, and it is designed to assess its safety and effects on your condition.

4 monitoring phase

After receiving the main treatment, you will enter a monitoring phase. During this time, you will have regular follow-up visits with the study team. These visits will include assessments to monitor your health and the effects of the treatment. You may undergo tests such as blood draws, brain MRI scans, and other evaluations to track your progress.

5 safety and progress evaluation

Throughout the study, the safety of the treatment will be closely monitored. The study team will evaluate any side effects or adverse events you may experience. Additionally, your progress will be assessed to determine any changes in your condition.

6 end of study

The study is expected to last until June 2030. At the end of the study, you will have a final visit where the study team will conduct a comprehensive evaluation of your health and the overall effects of the treatment.

Who Can Join the Study?

Participants must be male or female and between 18 to 60 years old at the time of screening.
Participants must provide signed informed consent before joining the study. This means they agree to participate after understanding the study details.
Participants must be able to communicate well with the study team and understand what the study involves. This includes being able to undergo certain procedures like a lumbar puncture (LP), which is a procedure to collect fluid from the spine, and a brain MRI, which is a type of scan.
Participants must have a diagnosis of Secondary Progressive Multiple Sclerosis (SPMS) or Primary Progressive Multiple Sclerosis (PPMS) based on specific criteria confirmed during the screening visit.
The duration of the disease must be less than 15 years.
Participants must be ambulatory, meaning they can walk, with an EDSS score between 3 to 6.5 at screening. The EDSS is a scale used to measure the level of disability in people with multiple sclerosis.

Who Cannot Join the Study?

Patients with any other type of Multiple Sclerosis (MS) that is not Non-active Progressive Multiple Sclerosis (PMS) cannot participate. Multiple Sclerosis is a disease that affects the brain and spinal cord.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important to be within the required age group.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Ufzrxrjbbytkdpmdfevel Efojy Afp	Essen	Germany
Cdwl Dx Ngrig	Vandoeuvre Les Nancy	France
Hzfepnjf Vuul dwgxephz	Barcelona	Spain
Hcsmtmpe Uabhcgegfsbnqc Sakvzwqmfe &lpftdi Hjndfmw da Hpdhhbgifhs	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	17.03.2026
Germany	Not yet recruiting	17.03.2026
Italy	Not yet recruiting	17.03.2026
Spain	Not yet recruiting	17.03.2026

Trial locations

Investigated drugs:

YTB323 is a new type of treatment being studied for people with a condition called Progressive Multiple Sclerosis (PMS). This treatment involves using special cells from your own body that are changed in a lab to help fight the disease. The goal of this study is to see if YTB323 is safe for people with PMS and to understand how it works in the body. By using these modified cells, researchers hope to slow down the progression of the disease and improve the quality of life for patients. This study is important because it explores a new way to treat PMS, which currently has limited treatment options.

Progressive Multiple Sclerosis – Progressive Multiple Sclerosis is a form of multiple sclerosis characterized by a gradual worsening of neurological function over time. Unlike relapsing forms, it does not involve distinct relapses or remissions. The disease primarily affects the central nervous system, leading to symptoms such as muscle weakness, coordination problems, and cognitive difficulties. As the disease progresses, individuals may experience increased disability and a decline in physical and mental abilities. The progression rate can vary significantly among individuals, with some experiencing a slow decline and others a more rapid deterioration. The exact cause of the disease is not fully understood, but it involves immune system attacks on the protective covering of nerve fibers.

Trial ID:

2024-514006-31-00

Protocol code:

CYTB323R12101

NCT ID:

NCT06675864

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of YTB323 and Drug Combination in Patients with Progressive Multiple Sclerosis

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