Not yet recruitingPHASE1INTERVENTIONAL

Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases

This study is investigating a new type of treatment called CAR-T cell therapy for adults with very tough-to-treat autoimmune diseases. These include conditions like rheumatoid arthritis, lupus (SLE), Sjogren's disease, systemic sclerosis, and a type of muscle inflammation called idiopathic inflammatory myositis. The treatment uses specially modified cells from the patient's own body to target and remove certain immune cells that are causing the disease. Researchers at Gustave Roussy are checking to see how safe this new treatment is, how well people can tolerate it, and if it shows early signs of helping to control these severe conditions. It's a small, early-stage study focusing on safety, for patients who haven't found relief with standard treatments.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrolment target

Start

01 Sep 2026

Estimated completion

01 Feb 2043

Rheumatoid Arthritis (RA)Systemic Lupus Erythematosus (SLE)Sjogren's Disease With Dry Eyes Systemic Sclerosis (SSc)Idiopathic Inflammatory Myositis (IIM)

What is this study about?

This research is looking into a new way to treat several serious autoimmune diseases. Autoimmune diseases happen when your body's immune system, which normally fights off infections, mistakenly attacks your own healthy tissues. Conditions like rheumatoid arthritis, lupus, Sjogren's disease, and others can cause a lot of pain and damage, and sometimes standard treatments don't work well enough.

The study is using a special treatment called CAR-T cell therapy. This treatment involves taking some of a person's own immune cells, called T-cells, and changing them in a lab. These modified T-cells are then put back into the patient's body. Their new job is to specifically find and destroy other immune cells that are causing the autoimmune disease. It's a bit like giving your body's immune system a highly trained special force to target the problem cells.

The main goal of this particular study is to check how safe this CAR-T cell treatment is for people with severe, hard-to-treat autoimmune diseases. It will also look at whether patients can handle the treatment well and if there are any early signs that it might be an effective way to help manage their condition. This is an early-stage study, so it's focused on understanding these basic things before it can be widely used.

Key takeaways

This is a study for adults with severe autoimmune diseases not responding to current treatments.
It uses a new type of cell therapy called CAR-T cells, made from your own blood.
The main goals are to check the treatment's safety, how well it's tolerated, and initial effectiveness.
It's an early-stage study, meaning the treatment is still in development.
Close medical monitoring will be provided throughout the study.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old. You must have one of the specific autoimmune rheumatic diseases mentioned (like rheumatoid arthritis, lupus, Sjogren's, systemic sclerosis, or idiopathic inflammatory myositis) that is severe and hasn't responded well to other treatments. It's important that your overall health is good enough to undergo the treatment, and key organs like your kidneys are working properly.

There are also reasons why you might not be able to join. For example, if you have a serious active infection, or have had certain types of cancer or organ transplants recently, you wouldn't be eligible. Your heart, liver, or lung function also needs to be strong enough. If you are pregnant, breastfeeding, or unwilling to use highly effective contraception for a year after treatment, you also won't be able 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 an adult aged 18 to 75 years old?
Do you have severe rheumatoid arthritis, lupus, Sjogren's, systemic sclerosis, or idiopathic inflammatory myositis that hasn't responded to other treatments?
Do you have good kidney, heart, and lung function?
Are you free from serious active infections like Hepatitis B/C or HIV?
Have you *not* had any organ or stem cell transplants, advanced cancer, or gene therapy before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a single dose of the CAR-T cell therapy. Before this, doctors will need to collect some of your blood to create your personalised cells. Throughout the study, you'll have regular hospital visits for blood tests, check-ups, and to see how you're responding to the treatment and identify any side effects. The medical team will closely monitor your health to make sure you are safe and to understand how the treatment is working. The exact number and frequency of visits, as well as the total duration of follow-up after the treatment, will be clearly explained by the study team. You will be given full details of what to expect every step of the way.

Potential risks and benefits

Taking part in an early-stage study like this means there are potential benefits, but also potential risks. A possible benefit is that this new CAR-T cell therapy might help control your severe autoimmune disease when other treatments haven't worked, potentially improving your quality of life. However, because this is a new treatment, there could be side effects that are not yet fully known, ranging from mild to serious. The study team will explain all known and potential risks to you in detail. Remember, joining a study is always your choice, and you have the right to withdraw at any time without affecting your future medical care.

Locations (1)

Gustave Roussy
Verified postcode
Villejuif, France

Common questions

What are CAR-T cells?

CAR-T cells are a special type of your own immune cells that have been changed in a lab to better fight certain diseases, in this case, to target the cells causing your autoimmune condition.

Is this a new treatment?

Yes, this is an investigational treatment, meaning it's still being tested in a clinical trial to see if it's safe and effective for autoimmune diseases. It's not yet available outside of studies like this one.

Will this cure my disease?

This early-stage study aims to see if the treatment is safe and shows early signs of helping to control the disease. It's too early to say if it will lead to a cure.

What if I feel unwell during the study?

The study team will monitor you very closely. If you feel unwell at any point, you should contact them immediately so they can assess you and provide any necessary care.

Will I have to pay to be part of this study?

No, you will not have to pay for the study treatment or for any research-related care. Medical costs that are part of your usual care may still apply, but this will be made clear to you.

How to find out more

Cristina CASTILLA-LLORENTE

cristina.castilla-llorente@gustaveroussy.fr +33(0)142114355 Official trial record

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