RecruitingPHASE1, PHASE2INTERVENTIONAL

Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)

This research trial is for people aged 2 to 70 years old with aggressive types of lymphoma or acute leukaemia (ALL) that has relapsed, meaning it has come back after previous treatment. The study is testing a new type of treatment called CAR T-cell therapy. This therapy involves taking some of your own immune cells (called T-cells) from your blood, modifying them in a lab to specifically target and kill cancer cells, and then giving them back to you. Before receiving these modified cells, you will have a short course of chemotherapy to prepare your body. The trial has two parts: an early phase to find the safest and most effective dose, and a later phase to further test its effectiveness. It aims to see if this new treatment can offer a different option for these conditions.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University of Alberta

Enrolment target

Start

03 Mar 2021

Estimated completion

01 Dec 2027

Relapsed Non Hodgkin Lymphoma Relapsed Adult ALL Relapsed Pediatric ALL

What is this study about?

This study is exploring a new way to treat certain types of blood cancer, specifically aggressive lymphoma and a form of leukaemia called Acute Lymphoblastic Leukaemia (ALL), when they have returned after earlier treatments. The treatment being tested is a type of immunotherapy called CAR T-cell therapy. Think of it like this: your body has its own defenders, called T-cells, which are part of your immune system. In CAR T-cell therapy, we take some of your own T-cells from your blood. In a lab, these cells are given a special instruction, like a new ability, that helps them recognise and attack cancer cells more effectively. Once these 'trained' cells are ready, they are given back to you through a drip.

Before you receive these special CAR T-cells, you will have a short course of chemotherapy. This chemotherapy helps to make space for the new CAR T-cells to work best in your body. The study is divided into two main parts. The first part, called Phase 1b, is about finding the right amount (dose) of these CAR T-cells to give that is both safe and has the best chance of working. Once the best dose is found, the second part, Phase 2, will involve more patients receiving this chosen dose to further evaluate how well the treatment works and its safety.

The main goal of this research is to see if this CAR T-cell therapy can be an effective and safe treatment option for people whose lymphoma or leukaemia has returned and for whom standard treatments might no longer be suitable. It's a cutting-edge approach that uses your own body's power to fight cancer, potentially offering hope where other treatments have been less successful.

Key takeaways

This is a new type of immune cell therapy for specific blood cancers that have returned.
It uses your own T-cells, modified to fight cancer.
A short course of chemotherapy is given before the main treatment.
The study is for patients, aged 2-70, with limited other treatment options.
It aims to find a safe and effective dose, then test it further.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is for people between 2 and 70 years old who have an aggressive type of lymphoma or Acute Lymphoblastic Leukaemia (ALL) that has come back after previous treatment. Your cancer cells must show a specific marker called CD19 for this treatment to work.

To be considered, you generally need to be reasonably fit for your age, as determined by a doctor. This includes having your kidneys and liver working well enough, unless any issues are directly caused by your cancer. You or your legal guardian (if you are under 18) must give written permission to take part.

Critically, this study is for patients who have already tried at least two other main treatments and are not good candidates for other standard treatments that might cure their disease. This means the study is looking for participants who have limited other treatment options available to them.

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 between 2 and 70 years old?
Has your aggressive lymphoma or ALL come back after previous treatment?
Have you already tried at least two other main treatments?
Are you generally well enough for treatment, with good kidney and liver function?
Are you unable to receive other standard, potentially curative, treatments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your journey would typically involve several key steps. First, blood will be taken to collect your T-cells. This is usually done through a process called apheresis, which is similar to donating blood but takes longer as only specific cells are collected. After your cells are collected, they will be sent to a lab to be specially prepared.

Before you receive your modified CAR T-cells, you will have a short course of chemotherapy, usually over three days. This chemotherapy helps prepare your body for the new cells. A few days later, you will receive the CAR T-cells as a single dose through a drip into your vein. Throughout this process, and for some time afterwards, you will have regular medical check-ups, blood tests, and scans to monitor your health, how well the treatment is working, and to keep an eye on any side effects.

Your participation will involve several hospital visits for these assessments. The total duration of your active involvement in the study, including follow-up, will be discussed by the study team, but generally, these types of therapies involve close monitoring for months after treatment. You will also need to provide past tumour samples or have a new biopsy if needed for research purposes.

Potential risks and benefits

Participating in this study might offer a potential benefit of a new treatment option for your advanced cancer, which standard treatments may no longer be able to manage. It gives you access to a cutting-edge therapy that is not yet widely available. However, like all medical treatments, particularly new ones, there are potential risks and side effects. These can include reactions to the chemotherapy, or side effects specifically from the CAR T-cells, such as fever, fatigue, or more serious immune reactions that the medical team will monitor closely. You will be fully informed of all known and potential risks before making a decision. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (6)

Foothills Medical Centre
Verified postcode
Calgary, Canada· Not yet recruiting
Tom Baker Cancer Centre
Verified postcode
Calgary, Canada· Not yet recruiting
Alberta Children's Hospital
Verified postcode
Calgary, Canada· Not yet recruiting
Cross Cancer Institute
Verified postcode
Edmonton, Canada· Recruiting
Stollery Children's Hospital
Verified postcode
Edmonton, Canada· Not yet recruiting
University of Alberta Hospital
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is CAR T-cell therapy?

It's a treatment where your own immune cells are specially trained in a lab to kill cancer cells, then given back to you.

Who can join this study?

People aged 2-70 with aggressive lymphoma or acute leukaemia that has come back, and who have tried other treatments.

Will I have chemotherapy?

Yes, you'll have a short course of chemotherapy before receiving the CAR T-cells to prepare your body.

How is the treatment given?

Your own cells are collected, modified, and then given back to you through a drip in your vein.

What if I change my mind about participating?

You can withdraw from the study at any time, and it won't affect your medical care.

How to find out more

Zack Breckenridge

zackariah.breckenridge@ahs.ca 7803917687 Official trial record

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