AuthorisedTherapeutic confirmatory (Phase III)Interventional

PREV-CART - A multicentric phase III randomized clinical trial open-label, comparing immunoglobulin replacement therapy (IgRT) and antibiotic prophylaxis (AP) in patients treated by CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for a B cell acute lymphoblastic leukemia or a B cell lymphoma

This study, called PREV-CART, is for adults with certain types of blood cancer (B-cell leukaemia or lymphoma) who are having a unique cell therapy called CAR T-cells. After this powerful treatment, people can be more prone to infections. Researchers want to compare two ways to prevent these infections: giving people extra protective antibodies (immunoglobulin replacement therapy) or giving them regular antibiotics. The main goal is to see which of these methods better prevents recurrent or severe infections that need hospital care over the 12 months following their treatment. This is a "Phase III" study, which means it's a large, important trial to confirm if one approach is more effective.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

228

Start

13 Apr 2026

Young Adults and adults with R/R B-cell acute lymphoblastic leukemia (BCP-ALL) or a B cell lymphoma (BCL)

What is this study about?

When you have certain types of blood cancer, like specific kinds of leukaemia or lymphoma, doctors might suggest a very advanced treatment called CAR T-cell therapy. This treatment uses your own immune cells, specially trained in a lab, to fight the cancer. While it can be very effective, it can also make your immune system weaker, increasing your risk of getting infections.

This study, called PREV-CART, wants to find the best way to protect people from infections after they’ve had CAR T-cell therapy. Doctors are comparing two different approaches. One approach involves giving you extra antibodies, which are like tiny soldiers in your immune system that help fight off germs. This is called immunoglobulin replacement therapy. The other approach is giving you regular antibiotic medicines to prevent bacterial infections.

The main aim of this study is to see which of these methods does a better job at preventing infections that keep coming back, or infections that are serious enough to need a hospital stay, within the first year after your CAR T-cell treatment. By doing this research, doctors hope to make CAR T-cell therapy safer and improve the health of people who receive it.

Key takeaways

The study aims to find the best way to prevent infections after CAR T-cell therapy.
It compares giving extra antibodies versus taking antibiotics.
Participation lasts for 12 months after your CAR T-cell treatment.
You would be closely monitored for infections and your general health.
This research hopes to improve safety for future patients receiving CAR T-cell therapy.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. You would be considered if you have a specific type of blood cancer called B-cell acute lymphoblastic leukaemia (BCP-ALL) or a B-cell lymphoma that has come back or hasn't responded to previous treatments.

Importantly, you would need to be scheduled to receive a special type of cell therapy called CD19-targeted CAR T-cell therapy. This study is designed to help prevent infections specifically related to that treatment.

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?
Do you have a specific type of B-cell leukaemia or lymphoma?
Is your cancer coming back or hasn't responded to past treatments?
Are you going to receive CD19-targeted CAR T-cell therapy soon?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to either receive extra protective antibodies or take antibiotic medicines after your CAR T-cell therapy. This means you wouldn't get to choose which one you receive, as this helps make the study fair and scientific. You would have regular check-ups with your medical team for 12 months after starting the study. These check-ups would involve blood tests to measure your immune cells and antibody levels, and you might be asked to fill out questionnaires about how you're feeling and your quality of life. The doctors will closely monitor you for any infections. The total duration of active participation and follow-up for the main study is 12 months.

Potential risks and benefits

Participating in this study might offer you the potential benefit of a carefully monitored approach to preventing infections after your CAR T-cell therapy, which could improve your well-being. However, there are potential risks, such as side effects from the extra antibodies or antibiotics, or the possibility that the prevention method doesn't work as well for you. Your doctors will explain all known side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your 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 are CAR T-cells?

CAR T-cells are your own immune cells that have been specially trained in a lab to find and fight cancer cells in your body.

Why do people get infections after CAR T-cell therapy?

CAR T-cell therapy can weaken your body's natural defence system, making it harder for you to fight off germs and leading to a higher risk of infections.

What's the difference between extra antibodies and antibiotics?

Extra antibodies (immunoglobulins) are like natural defenders that boost your immune system. Antibiotics are medicines that kill harmful bacteria.

Will I know which treatment I'm getting?

Yes, this is an "open-label" study, meaning both you and your medical team will know whether you are receiving extra antibodies or antibiotics.

What happens if I get a serious infection while in the study?

Your medical team will provide the necessary treatment for any infections you get, regardless of which group you are in. The study aims to compare how often these infections happen.