Active not recruitingPHASE1INTERVENTIONAL

Immunotherapy for High Risk/Relapsed CD19+ Acute Lymphoblastic Leukaemia, B-cell Non-Hodgkin's Lymphoma (B-NHL) and Chronic Lymphocytic Leukaemia (CLL)/ Small Lymphocytic Lymphoma (SLL) Using CAR T-cells to Target CD19

This study is testing a new treatment called CAR T-cell therapy for adults (aged 16 and over) with specific types of blood cancer: acute lymphoblastic leukaemia, certain non-Hodgkin lymphomas, and chronic lymphocytic leukaemia/small lymphocytic lymphoma. These are cancers that haven't responded well to previous treatments or have returned. The therapy involves taking a patient's own immune cells, called T-cells, and genetically modifying them in a lab to better recognise and attack cancer cells. These modified cells are then given back to the patient. This early-stage study (Phase 1) primarily aims to understand how safe this new treatment is and how well patients tolerate it, as well as if it can shrink the cancer and how long any improvements last. Recruitment for leukaemia patients has finished.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

University College, London

Enrolment target

Start

29 Sep 2017

Estimated completion

01 Dec 2033

Leukemia, Lymphoblastic, Acute, Lymphoma

What is this study about?

This study is exploring a new type of treatment called CAR T-cell therapy for adults with certain blood cancers that have either returned after treatment or are considered high-risk. These cancers include acute lymphoblastic leukaemia, some types of non-Hodgkin's lymphoma (like diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma), and chronic lymphocytic leukaemia/small lymphocytic lymphoma.

CAR T-cell therapy is a very advanced and personal form of treatment. It starts with taking some of your own blood. From this blood, a specific type of immune cell called a T-cell is collected. These T-cells are then sent to a lab where they are specially trained to recognise and fight cancer cells. This 'training' involves adding a new gene to them, turning them into what are called 'CAR T-cells'. These modified cells are then multiplied and given back to you through an infusion, like a drip. The whole process, from collecting your cells to getting the treatment, takes about 15 days, during which you might receive some regular chemotherapy to keep your cancer under control.

This is a Phase 1 study, which means it's one of the first times this specific CAR T-cell treatment is being tested in people. The main goals are to find out if the treatment is safe, what side effects it might cause, and to see if it helps fight the cancer. We also want to understand how long any positive effects of the treatment might last. For some types of lymphoma involved in the study, participants might also receive a separate, additional medication called pembrolizumab before the CAR T-cells.

Key takeaways

Tests a new personalised cell treatment for certain hard-to-treat blood cancers.
Uses your own immune cells, specially trained to fight cancer.
Aims to check safety and how well it works in early-stage trials.
Involves cell collection, chemotherapy, and then receiving the modified cells.
Long-term follow-up for up to 10 years is required.
Recruitment for acute leukaemia patients has now finished.

Who may be eligible?

To be considered for this study, you need to be at least 16 years old. You must have one of the specific blood cancers mentioned – acute lymphoblastic leukaemia, certain non-Hodgkin lymphomas, or chronic lymphocytic leukaemia – and these must have either come back or not responded to previous standard treatments.

There are also some important reasons why you might not be able to join. For example, if your cancer doesn't have a specific marker called CD19, this treatment won't work. Also, if the cancer has spread to your brain or spinal cord in a noticeable way, or if it's only found outside the bone marrow (for leukaemia), you might not be eligible. Severe heart problems, very poor kidney or liver function, active hepatitis B or C, or HIV infection could also prevent you from joining.

Additionally, if you are pregnant or breastfeeding, unable to undergo the cell collection procedure, have significant issues from a past stem cell transplant, or have certain neurological conditions, you would not be able to take part. Your medical team will carefully check all these factors to see if the study is right for you.

Quick self-check

Are you 16 years old or older?
Do you have a specific type of leukaemia or lymphoma that has returned or is high-risk, and has the cancer cells have the CD19 marker?
Are you able to undergo a procedure to collect your blood cells?
Do you have good general health, including healthy heart, kidney, and liver function?
Are you not pregnant or breastfeeding, and not currently experiencing certain other serious health conditions?

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

What does participation involve?

If you decide to participate, the first step is a procedure called 'leukapheresis'. This is similar to donating blood, where your blood is collected, and specific immune cells are separated and then the rest of your blood is returned to you. These cells are then sent to a special lab to be modified into CAR T-cells, which takes about 15 days. During this waiting period, you might receive some standard chemotherapy to manage your cancer.

Before you receive the CAR T-cells, you will have a short course of chemotherapy over a few days to prepare your body. Then, the CAR T-cells will be given to you through a drip. Some patients will receive a single dose, while others with certain types of leukaemia or chronic lymphocytic leukaemia will receive a smaller first dose, followed by a second dose about nine days later, if they don't experience severe side effects. Throughout the study, you will have regular hospital visits for various tests and checks to monitor your health, how the treatment is affecting you, and how your cancer is responding. After the main treatment, all patients will be followed up for a long time, up to 10 years, even if their cancer progresses or responds well, to understand the long-term effects of the treatment.

Potential risks and benefits

Participating in this study might offer the potential benefit of trying a new and advanced treatment for your cancer when other standard treatments haven't worked or are no longer suitable. It could potentially help control or even shrink your cancer. However, this is an early-stage study, so the full benefits are not yet known. Like all medical treatments, CAR T-cell therapy carries potential risks and side effects, some of which can be serious, as your immune system is being activated. Your care team will explain all known potential side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University College London Hospital
London, United Kingdom

Common questions

What is CAR T-cell therapy?

It's a treatment where your own immune cells, called T-cells, are specially trained in a lab to find and fight your cancer, then given back to you.

Will I have to stay in the hospital?

You will need several hospital visits for cell collection, chemotherapy, and receiving the CAR T-cells. There will also be regular follow-up appointments, which may involve hospital stays.

What kind of cancers is this study for?

This study is for specific types of acute leukaemia and certain lymphomas that have returned or are high-risk.

Is the treatment guaranteed to work?

No, this is an early-stage study, so we are learning about its effectiveness. There's no guarantee it will work for everyone.

How long will I be involved in the study?

You'll be followed up for several years after the treatment, up to 10 years, to understand the long-term effects.