Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Open-Label, Phase 2 Study Evaluating Lymphodepletion With Fludarabine, Cyclophosphamide, And ALLO-647, Vs. Fludarabine And Cyclophosphamide Alone, In Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL) Receiving ALLO-501A Allogeneic CAR T Cell Therapy

This research study is looking for people with a type of blood cancer called Large B-Cell Lymphoma (LBCL) where previous treatments haven't worked or the cancer has returned. The study aims to find out if adding a new medicine, ALLO-647, to standard preparation treatments (Fludarabine and Cyclophosphamide) makes a pioneering cell therapy (ALLO-501A) more effective. This cell therapy works by using specially modified immune cells to fight the cancer. We want to see if this new combination helps the therapy work better and for longer, and if it's safe. It's a Phase 2 study, meaning we're still gathering information on how well the new treatment works and its side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Allogene Therapeutics Inc.

Enrolment target

Start

23 Aug 2023

Large B-Cell Lymphoma (LBCL)

What is this study about?

This study is investigating a new approach for people living with a serious blood cancer called Large B-Cell Lymphoma, specifically when the cancer has either come back or hasn't responded to previous treatments. We are focusing on a cutting-edge treatment known as CAR T cell therapy, which uses a patient's own immune cells, specially trained to fight cancer. In this particular study, the CAR T cells come from a donor, rather than the patient themselves. Before these special cells are given, patients need a 'preparation' treatment to make space for the new cells in their body. This preparation often involves medicines like Fludarabine and Cyclophosphamide.

The main goal of this study is to see if adding another medicine called ALLO-647 to the usual preparation (Fludarabine and Cyclophosphamide) makes the CAR T cell therapy, named ALLO-501A, more successful. We are particularly interested in how long it takes for the cancer to show signs of returning or getting worse after treatment. This will help us understand if the new combination of preparation medicines helps the CAR T cells work better and provides a longer-lasting effect against the lymphoma.

This is a 'Phase 2' study, which means it’s an important step in developing new treatments. We are looking closely at how effective the treatment is, how it affects the body, and what side effects might occur. By comparing two different ways of preparing the body for CAR T cell therapy, we hope to find a safer and more effective option for people with Large B-Cell Lymphoma.

Key takeaways

This study is for adults with Large B-Cell Lymphoma that has returned or not responded to prior treatment.
It tests if adding a new medicine (ALLO-647) improves CAR T cell therapy (ALLO-501A).
The main goal is to see if the new combination prevents cancer from returning for longer.
Participation involves receiving one of two preparation treatments, followed by CAR T cell therapy.
You'll have regular medical check-ups, blood tests, and scans.
It's a Phase 2 trial, focused on effectiveness and safety of a new treatment approach.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. The study is open to both men and women.

The main requirement is that you have been diagnosed with Large B-Cell Lymphoma (LBCL) that has either come back after previous treatments or hasn't responded to those treatments.

There will be other detailed criteria that your doctor will discuss with you. These make sure that the study is safe for you and that the results will be clear.

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 18 years old or older?
Have you been diagnosed with Large B-Cell Lymphoma (LBCL)?
Has your lymphoma either returned or not responded to previous treatments?
Are you able to travel to a study site for regular appointments?
Are you willing to potentially receive either the standard preparation or the new one?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly assigned to one of two groups – similar to flipping a coin. One group will receive the standard preparation medicines (Fludarabine and Cyclophosphamide), and the other group will receive these same medicines with the addition of ALLO-647. Following this preparation, you will receive the ALLO-501A CAR T cell therapy.

Participation will involve several visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and the cancer's response. You'll also receive various other medications like Paracetamol, antibiotics (PREVYMIS), steroids (Solu-Cortef), and anti-sickness drugs (Phenergan, Quamatel, Loratadine) as needed to support your health and manage potential side effects. The study team will regularly assess how you are feeling and how your body is responding to the treatment. This will include checking for specific immune cell counts and how long the specially designed cells stay in your body. We don't have a fixed total duration listed, but these types of studies typically involve close monitoring for many months, and sometimes years, after the main treatment.

Potential risks and benefits

Taking part in a clinical trial has both potential benefits and risks. For some people, this study might offer access to a new treatment approach that isn't available outside of the trial. While we hope the new treatment combination will be more effective, there's no guarantee it will work for everyone. As with any medical treatment, there's a risk of side effects, which could be mild or serious. The study team will monitor you closely for any unwanted effects and will work to manage them. You are always free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium
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Unverified
Germany
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Unverified
Austria

Common questions

What is Large B-Cell Lymphoma (LBCL)?

It's a type of fast-growing cancer that starts in certain white blood cells called lymphocytes.

What is CAR T cell therapy?

It's a treatment where special immune cells are modified in a lab to find and destroy cancer cells.

What does 'relapsed/refractory' mean?

It means the cancer has come back after treatment (relapsed) or hasn't responded to previous treatments (refractory).

What is the purpose of the preparation medicines?

They help prepare your body for the CAR T cells, making space for them to work effectively against the cancer.

Will I know which treatment group I am in?

Yes, this is an 'open-label' study, meaning both you and the study team will know which treatment you are receiving.