Active not recruitingPHASE1INTERVENTIONAL

A Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia

This study is testing a new way to treat certain kinds of leukaemia and lymphoma, especially when they have returned or haven't responded to previous treatments. It uses your own immune cells, called T-cells, which are collected and then modified in a lab. These modified T-cells are designed to recognise and kill specific cancer cells by targeting two markers, CD19 and CD22, found on the cancer cell surface. By targeting both, we hope to improve how well the treatment works and stop the cancer from becoming resistant. This first phase of the study is mainly checking if this new treatment is safe and if we can successfully make enough of these special T-cells for patients.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Seattle Children's Hospital

Enrolment target

Start

03 Nov 2017

Estimated completion

03 Mar 2035

Leukemia Lymphoma

What is this study about?

When people have leukaemia or lymphoma that has returned or hasn't responded well to standard treatments like chemotherapy, it can be very difficult to treat. Sometimes, after treatments that target a specific protein on cancer cells called CD19, the cancer can change and no longer have that protein, making it harder to fight.

This study is exploring a new type of treatment called CAR-T cell therapy. It involves taking some of your own immune cells, called T-cells, and genetically modifying them in a laboratory. These modified T-cells are given special instructions to recognise and attach to not just one, but two specific proteins, CD19 and CD22, which are often found on the surface of leukaemia cells. This 'dual targeting' approach is designed to make the treatment more effective and potentially prevent the cancer from escaping by losing one of these targets.

The main goal of this particular study is to check if this new dual-target CAR-T cell therapy is safe for patients with CD19+CD22+ leukaemia. Researchers also want to see if they can reliably produce enough of these specially modified T-cells for each patient. It's an early-stage study, meaning it's one of the first times this specific treatment is being tested in people.

Key takeaways

New experimental treatment for certain leukaemias.
Uses your own modified immune cells (CAR-T cells).
Targets two specific markers (CD19 and CD22) on cancer cells.
Early-stage study focused on safety and feasibility.
Requires long-term health monitoring for up to 15 years.

Who may be eligible?

This study is for adults with certain types of leukaemia that express both CD19 and CD22. These are specific markers found on the cancer cells. You might be considered if your leukaemia has returned after treatment, or if it hasn't responded to previous treatments, even if you've already had a bone marrow transplant.

There are also some health requirements. For example, if you have any problems in your brain or spinal cord due to the cancer, they should not be causing severe symptoms and need to be stable. You shouldn't have active graft-versus-host disease (GVHD) if you've had an allogeneic transplant, and you must have stopped any medicines for GVHD a few weeks before joining. Your general health and organ function need to be good enough to safely take part in the study.

If you're interested, you'll need to be well enough to manage the process, with a good level of day-to-day activity. You also need to have recovered from any recent chemotherapy or other treatments before starting this study. Importantly, you must be willing to participate in long-term follow-up for many years if you receive the cell infusion.

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.

Do I have CD19+CD22+ leukaemia?
Has my leukaemia come back or not responded to previous treatments?
Am I generally well enough to participate, with good organ function?
Have I recovered from any recent chemotherapy or other cancer treatments?
Am I able to commit to long-term follow-up appointments?
If I've had a bone marrow transplant, is my 'graft-versus-host disease' stable or gone?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step involves having some of your blood collected. From this blood, your T-cells will be separated and sent to a special lab where they will be genetically modified to create the CAR-T cells. This process can take several weeks. During this time, you might receive some 'bridging' chemotherapy to help control your leukaemia until your CAR-T cells are ready.

Before you receive the modified T-cells, you will have a short course of chemotherapy to prepare your body. Then, the modified CAR-T cells will be given to you through an intravenous drip, similar to a blood transfusion. After the infusion, you will be closely monitored in the hospital for any side effects. You will have regular check-ups, blood tests, and scans for several months after the treatment to see how well it's working and to check for any ongoing side effects.

Following this initial period, you will have follow-up appointments less frequently, but the study requires you to agree to long-term monitoring for up to 15 years to track the long-term effects of the modified cells. The total duration of active treatment and close monitoring will be a few months, followed by these longer-term check-ups.

Potential risks and benefits

Potential benefits of participating in this study include the chance to receive a new, experimental treatment for your leukaemia that may be more effective than standard options, especially if your cancer has come back or not responded to previous therapies. However, as this is an early-stage study, the primary aim is to assess safety, and there's no guarantee the treatment will work for you. Potential risks include side effects from the chemotherapy given before the CAR-T cells, and specific side effects related to the CAR-T cells themselves, which can sometimes be serious and affect various organs. You will be closely monitored for these. It is important to remember that you can withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (5)

Children's Hospital Los Angeles
Verified postcode
Los Angeles, United States
Children's National Medical Center
Verified postcode
Washington D.C., United States
Riley Hospital for Children
Verified postcode
Indianapolis, United States
Seattle Children's Hospital
Verified postcode
Seattle, United States
Children's and Women's Health Centre of British Columbia
Verified postcode
Vancouver, Canada

Common questions

What are CD19 and CD22?

These are specific proteins, like small flags, found on the surface of some leukaemia cells. This study uses a treatment that targets both of these flags at the same time.

What are CAR-T cells?

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

Is this a new treatment?

Yes, this specific treatment combining two targets (CD19 and CD22) is new and is being tested for the first time in people to see if it's safe.

What is a 'Phase 1' study?

A Phase 1 study is the first step in testing a new treatment in humans. Its main purpose is to check if the treatment is safe and to find the right dose, rather than to prove how well it works.

How long will I be followed after treatment?

The study requires long-term follow-up for up to 15 years to monitor your health and the effects of the treatment over time.