AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase IIa Trial Evaluating the Efficacy of anti-CD19 Chimeric Antigen Receptor Engineered T-Cells in Patients With Systemic Sclerosis (SSc) Resistant to Immunosuppressive Drugs. SCLEROCAR

This research study, called SCLEROCAR, is looking into a new treatment for systemic sclerosis (also known as scleroderma), a condition that affects your skin and internal organs. The treatment, called MB-CART19.1, uses your own immune cells (T-cells) which are specially modified in the lab to target certain 'B-cells' that are thought to be involved in the disease. This is a Phase II study, meaning it's exploring how effective and safe this new therapy is. We're particularly interested in people whose scleroderma is still active and stable, or has worsened, even after trying several standard treatments including immunosuppressants. The main goal is to see if the treatment can significantly improve toughened skin over six months, alongside closely monitoring other disease signs, lung and heart function, and your overall well-being.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Montpellier

Enrolment target

Start

07 Nov 2025

azathioprine mycophenolate mofetil) and/or a biological DMARD (rituximab or tocilizumab) for at least 6 months.

What is this study about?

This study is called SCLEROCAR and it's looking at a new type of treatment for systemic sclerosis (sometimes just called scleroderma). Systemic sclerosis is a condition where your immune system mistakenly attacks your own body, leading to a build-up of scar tissue (fibrosis) in the skin and sometimes in internal organs like the lungs, heart, or kidneys.

The new treatment we're testing is called MB-CART19.1. It's a bit like a highly personalised medicine. Doctors will take some of your own immune cells, specifically a type called T-cells, and send them to a lab. In the lab, these T-cells are specially trained to recognise and remove certain other immune cells (called B-cells) that are thought to play a role in systemic sclerosis. Once they're ready, these 'trained' T-cells are put back into your body through an infusion.

The main aim of this study is to see if this treatment can improve the hardness and thickness of your skin, which is often a key problem in systemic sclerosis. We'll be carefully measuring your skin thickness, among other things, over six months to see if there's a good improvement. We'll also be closely watching other important aspects of your health, like how well your lungs and heart are working, how you feel overall, and, most importantly, if the treatment is safe for you. This is a Phase II study, which means we're evaluating how well the treatment works and its safety in a group of patients.

Key takeaways

This study is for adults with active systemic sclerosis not responding to other treatments.
It uses a new cell therapy (MB-CART19.1) that modifies your own immune cells.
The main goal is to see if the treatment improves skin thickness over 6 months.
Researchers will also check lung function, heart health, and your overall well-being.
It's a Phase II study, meaning we are exploring how effective and safe this new therapy is.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older – there's no upper age limit.

The study is for people who have been diagnosed with systemic sclerosis and whose condition is still active, even though it might be stable, or has gotten worse. This includes people who have already tried several other treatments for at least six months. These treatments would typically be medicines that calm down your immune system, like methotrexate, azathioprine, mycophenolate, or stronger biological medicines like rituximab or tocilizumab.

Ultimately, a study doctor will carefully review your medical history and test results to decide if this study is right for you and if it's safe for you to take part.

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 old or older?
Have you been diagnosed with systemic sclerosis?
Is your systemic sclerosis still active or getting worse, despite treatment?
Have you tried at least two different immune-suppressing medications for 6 months or more?
Are you comfortable attending regular clinic visits and having various medical tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new treatment, MB-CART19.1. Before, during, and after this treatment, you will have several visits to the clinic. These visits will involve various checks and tests to monitor your health and how the treatment is working. This will include physical exams, blood tests (to check your immune cells and general health), and specific assessments of your skin, such as measuring its thickness. We'll also do tests to check your lung function (like how much air you can breathe in and out) and your heart function (ultrasounds). You'll also be asked to fill out questionnaires to share how you're feeling and how the disease is affecting your daily life. The main assessment period will be for six months after you receive the treatment, but there will be ongoing follow-up to monitor your health and safety.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that the new treatment, MB-CART19.1, might improve your symptoms of systemic sclerosis, especially the skin changes, and potentially help with organ involvement, if other treatments haven't worked well for you. However, as this is a new and experimental treatment, there could also be side effects or risks that we don't fully understand yet. These will be carefully explained to you by the study team, and you will be closely monitored for any reactions during the study. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

—
Unverified
France

Common questions

What is systemic sclerosis?

It's a long-term condition where your immune system attacks your body, causing too much scar tissue in your skin and sometimes your internal organs.

What does 'CAR T-cells' mean?

It refers to a special type of your own immune cells (T-cells) that are modified in a lab to specifically target and remove other cells (B-cells) involved in your condition.

Is this a new medicine?

Yes, MB-CART19.1 is a new treatment being explored in a clinical trial. It's not yet a standard approved medicine for systemic sclerosis.

How long will the treatment take?

The main part of the study assessing the treatment's effect and safety will be for six months after you receive the cell therapy.

Will this cure my systemic sclerosis?

This is a research study to see if the treatment can improve symptoms and disease activity. It's too early to say if it could lead to a cure.