RecruitingOBSERVATIONAL

Determining the Mechanisms of Loss of CAR T Cell Persistence

This study is for children and young adults (up to 25 years old) who have a type of blood cancer called acute lymphoblastic leukaemia (ALL) that has come back or not responded to other treatments. These patients will be receiving a new, specialised treatment called CAR T-cell therapy. This therapy uses the patient's own immune cells, which are specially trained to find and destroy cancer cells. The main goal of this study is to observe and understand why these CAR T-cells might become less effective over time. By looking at how these cells change, researchers hope to discover what might be causing them to stop working as well, which could lead to better treatments in the future.

At a glance

Status

Recruiting

Sponsor

University College, London

Enrolment target

Start

18 Oct 2023

Estimated completion

01 Jul 2027

Acute Lymphoblastic Leukemia With Failed Remission Acute Lymphoblastic Leukemia Not Having Achieved Remission Acute Lymphoblastic Leukemia, Pediatric Acute Lymphoblastic Leukemia, Adult Acute Lymphoblastic Leukemia, in Relapse

What is this study about?

This study is focused on understanding how a special type of cancer treatment, called CAR T-cell therapy, works in children and young adults with acute lymphoblastic leukaemia (ALL). ALL is a type of cancer that affects the blood and bone marrow. Sometimes, this cancer can be difficult to treat, or it might come back after initial treatments. CAR T-cell therapy is a newer approach where a patient's own immune cells are collected, modified in a lab to better fight cancer, and then given back to the patient.

The study aims to look closely at these modified immune cells, called CAR T-cells, over a period of time after they have been given to patients. The researchers want to see how long these cells stay active and if their ability to fight cancer changes. They are particularly interested in finding out why, for some patients, the CAR T-cells might not continue to work as well over time, or why their numbers might decrease.

By observing these patients and their CAR T-cells, the researchers hope to uncover the reasons behind any changes in the cells' effectiveness. This knowledge is really important because it could help doctors and scientists improve CAR T-cell therapy in the future, making it more successful and longer-lasting for patients with leukaemia. This study is an 'observational' one, which means participants will receive their standard CAR T-cell treatment, and the study team will collect information and samples as part of their routine care.

Key takeaways

The study is for children and young adults (up to age 25) with specific types of leukaemia.
It aims to understand why CAR T-cells might become less effective over time.
Participants will receive standard, approved CAR T-cell treatment.
It's an observational study, meaning no new medicines or procedures are given for the study itself.
Participation involves providing extra samples (e.g., blood) during routine hospital visits.
The goal is to improve future CAR T-cell therapies for leukaemia patients.

Who may be eligible?

This study is looking for children and young adults who are 25 years old or younger. To be considered, you must have acute lymphoblastic leukaemia (ALL) that has either come back after treatment or hasn't responded well to previous treatments.

You also need to be planning to receive a specific type of CAR T-cell therapy called Tisagenlecleucel, which is a licensed treatment. Lastly, you or your parent/guardian (if you're under 16) must be able to understand and sign a consent form to agree to take part.

You wouldn't be able to join this study if you are already receiving a different type of CAR T-cell treatment as part of another research study. Also, if the study doctors believe there's a reason you wouldn't be able to follow the study plan, you might not be able to participate.

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 25 years old or younger?
Do you have acute lymphoblastic leukaemia (ALL) that has relapsed or not responded to previous treatment?
Are you scheduled to receive Tisagenlecleucel CAR T-cell therapy?
Are you able to understand and sign a consent form (or is your parent/guardian able to)?
Are you currently NOT receiving a different CAR T-cell product as part of another research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the standard CAR T-cell treatment (Tisagenlecleucel) for your acute lymphoblastic leukaemia. The study itself won't involve any extra treatments or medications beyond what your doctor would normally prescribe for your care. Your participation will involve allowing the research team to collect information and samples (like blood samples) during your regular hospital visits and check-ups. They will be observing how your CAR T-cells behave over time.

There won't be any additional hospital visits specifically for this study; everything will be integrated into your usual care schedule. The researchers will be looking at changes in your CAR T-cells and collecting data for an unspecified period, likely during your regular follow-up appointments after receiving the CAR T-cell therapy. The total duration of your participation will depend on the study's plan for monitoring, but it will fit around your existing treatment and follow-up care.

Potential risks and benefits

The main benefit of taking part in this study is that it contributes to a better understanding of CAR T-cell therapy, which could help improve treatments for future patients with leukaemia. You will be receiving a licensed CAR T-cell treatment as part of your standard care, and this study will not change that treatment. However, as with any medical procedure, CAR T-cell therapy itself has potential risks, which your doctor will discuss with you in detail. For the study specifically, the risks are mainly related to providing extra samples (like blood draws) during your routine care, which may cause minor discomfort or bruising. You are free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (3)

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

Common questions

What is CAR T-cell therapy?

It's a special treatment that uses your own immune cells, which are trained in a lab to find and destroy cancer cells more effectively.

Will I get a new treatment if I join this study?

No, you will receive the standard, approved CAR T-cell treatment (Tisagenlecleucel) that your doctor has already planned for you. This study just observes how it works.

What does 'observational study' mean?

It means the researchers will watch and collect information about your health and treatment as part of your routine care, without giving you any extra medicines or procedures just for the study.

Will my care be different if I join the study?

Your medical care for your leukaemia will not change. The study will mainly involve collecting extra information and samples during your regular appointments.

How long will I be in the study?

The study will collect information during your regular follow-up visits after your CAR T-cell treatment. The exact duration will be explained by your study doctor.

How to find out more

CARPERS Trial Manager

ctc.carpers@ucl.ac.uk 442031084189 Official trial record

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