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RecruitingPHASE1INTERVENTIONAL

CARPALL: Immunotherapy With CD19+CD22 CAR T-cells for CD19+ and CD22+ Acute Lymphoblastic Leukaemia

This study is for children and young adults up to 24 years old who have acute lymphoblastic leukaemia (ALL) that is difficult to treat or has returned. Researchers are investigating a new type of treatment called CAR T-cell therapy. This involves taking some of your own immune cells, called T-cells, and re-engineering them in a lab to specifically recognise and fight the leukaemia cells. These special cells, called CD19+CD22 CAR T-cells, are then put back into your body to help your immune system attack the cancer. The main goal is to find out if this treatment is safe, if it works well in fighting the cancer, and how long its effects last for patients.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
University College, London
Enrolment target
50
Start
01 Apr 2016
Estimated completion
31 Dec 2041

What is this study about?

This study is looking into a new way to treat a type of blood cancer called acute lymphoblastic leukaemia, or ALL, especially when it has been difficult to treat or has come back after other treatments. This new approach uses something called CAR T-cell therapy. Think of your body's immune system as an army that fights off infections and diseases, including cancer.

In this treatment, doctors take some special fighting cells, called T-cells, from your own blood. These T-cells are then sent to a lab where they are genetically modified. This means they are given new instructions, like putting a new targeting system on them, to help them recognise two specific markers on the leukaemia cells, called CD19 and CD22. Once these T-cells have been retrained, they are called CD19+CD22 CAR T-cells. They are then given back to you through a drip, ready to specifically seek out and destroy the leukaemia cells in your body.

Before you receive these special CAR T-cells, you will have some chemotherapy and radiotherapy to prepare your body. The main purpose of this study is to see how safe this new treatment is, how well it works in children and young adults with this type of ALL, and how long the treatment's benefits last.

Key takeaways

  • This study is testing a new cell therapy for children and young adults with ALL.
  • It uses your own immune cells, specially modified to fight cancer.
  • The goal is to see if the treatment is safe and effective.
  • It's for ALL that is high-risk, difficult to treat, or has returned.
  • You'll have regular check-ups to monitor your health and the treatment's effects.

Who may be eligible?

This study is specifically designed for children and young adults, from any age up to 24 years old, who are battling a type of blood cancer called acute lymphoblastic leukaemia (ALL). There are certain situations that make a patient suitable for this study. For instance, if their ALL has not responded well to previous treatments, has returned after treatment, or has certain genetic features that make it high-risk.

More specifically, patients might be considered if their leukaemia has shown signs of being resistant to standard treatments, if it has come back sooner than expected, or if it involves a very young child with a particular aggressive form of ALL. Also, if a patient has had ALL relapse after a stem cell transplant, or if other CAR T-cell treatments haven't fully worked for them, they might be eligible. Your doctor will be able to tell you if your specific situation fits the criteria for this study.

Quick self-check
  • Are you 24 years old or younger?
  • Do you have a type of blood cancer called acute lymphoblastic leukaemia (ALL)?
  • Has your ALL not responded well to previous treatments, or has it come back?
  • Has a doctor told you your ALL is considered 'high-risk' or has certain genetic features?
  • Are you able to undergo procedures like blood collection and chemotherapy?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the first step is called 'leukapheresis'. This is a procedure similar to donating blood, where some of your blood is taken, and your white blood cells (which contain the T-cells) are separated out. The rest of your blood is returned to you. These T-cells will then be sent to a special lab to be modified into the CD19+CD22 CAR T-cells.

Before you receive your modified CAR T-cells, you will have some chemotherapy and radiotherapy (called Total Body Irradiation). These treatments help prepare your body for the CAR T-cells. Afterwards, the special CAR T-cells will be given back to you through a drip into your vein. Throughout the study, you will have regular check-ups, blood tests, and scans to monitor your health, how well the treatment is working, and to look for any side effects. The total duration of your participation, including follow-up, will be discussed by the study team.

Potential risks and benefits

Participating in this study might offer a chance to receive a new, cutting-edge treatment that could potentially help fight your leukaemia, especially if other treatments haven't been successful. However, all medical treatments come with potential risks. You might experience side effects from the chemotherapy, radiotherapy, or the CAR T-cell therapy itself. These side effects can range from mild to severe, and the study team will carefully monitor you for them. It's very important to remember that participating is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (3)

  • Great Ormond Street Hospital
    London, United Kingdom· Recruiting
  • University College Hospital
    London, United Kingdom· Recruiting
  • Manchester Royal Children's Hospital
    Manchester, United Kingdom· Recruiting

Common questions

What is acute lymphoblastic leukaemia (ALL)?

ALL is a fast-growing cancer of the blood and bone marrow, affecting types of white blood cells called lymphocytes.

What are CAR T-cells?

CAR T-cells are your own immune cells that have been specially trained in a lab to recognise and kill cancer cells more effectively.

Is this a new treatment?

Yes, this is an investigational treatment, meaning it's still being tested in a clinical trial to understand its safety and effectiveness.

What does 'relapsed' mean?

Relapsed means the cancer has returned after a period of improvement from previous treatments.

Will I have to stay in the hospital?

You will likely need to stay in the hospital for some parts of the treatment and for close monitoring afterwards, but the exact schedule will be explained to you.

How to find out more

Aniqa Tasnim

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

Interested in taking part?

Register your interest

Share your details and the research team for "CARPALL: Immunotherapy With CD19+CD22 CAR T-cells for CD19+ …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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