Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)

This study is testing a new treatment called KTE-X19 for a blood cancer called Mantle Cell Lymphoma. It's for patients whose cancer has either come back after earlier treatments (relapsed) or hasn't improved with those treatments (refractory). This is a 'Phase 2' study, which means researchers are checking how effective the treatment is at shrinking the cancer. They are also looking at its safety and how it affects patients' quality of life. The study uses a mix of existing medicines and the new KTE-X19 treatment. The main goal is to see how many people have their cancer shrink or disappear after treatment. This research could help bring new options to people living with Mantle Cell Lymphoma.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Kite Pharma Inc.

Enrolment target

Start

19 Dec 2023

Relapsed/Refractory Mantle Cell Lymphoma

What is this study about?

This clinical trial, called ZUMA-2, is a Phase 2 study focused on a new treatment named KTE-X19 for people with Mantle Cell Lymphoma. Mantle Cell Lymphoma is a type of cancer that affects white blood cells. This study is specifically for individuals whose cancer has either returned after they've had other treatments (this is called 'relapsed') or when previous treatments haven't worked well (this is called 'refractory'). It's important to find new options for these patients.

In a Phase 2 study, researchers are primarily looking to see how well a new treatment works, alongside checking its safety. They want to understand if KTE-X19 can shrink the cancer or make it disappear. They will measure this by looking at how many patients have their cancer either completely or partially respond to the treatment, using special scans and checks reviewed by expert radiologists.

Beyond just shrinking the cancer, the study will also look at how long any positive effects last, how long people live without their cancer getting worse, and their overall survival. Importantly, the study will also keep a close eye on any side effects and how the treatment affects patients' general well-being and quality of life. The aim is to gather as much information as possible to see if KTE-X19 could become a useful new treatment option.

Key takeaways

This study is for adults with Mantle Cell Lymphoma that is relapsed or refractory.
It's testing a new treatment called KTE-X19.
The main goal is to see how well KTE-X19 shrinks the cancer.
Researchers will also check for side effects and effects on quality of life.
Other medicines will be given alongside KTE-X19.
It's a Phase 2 study, meaning the treatment is still investigational.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older. The study includes both men and women.

The most important requirement is that you have Mantle Cell Lymphoma that has either returned after previous treatments or hasn't responded to them.

There will also be other specific health checks and medical history requirements that the study doctors will review to make sure the study is right and safe for you.

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?
Do you have Mantle Cell Lymphoma?
Has your Mantle Cell Lymphoma come back after treatment or not responded to past treatments?
Are you able to attend regular hospital visits for check-ups and treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new treatment KTE-X19, along with a combination of other medicines. These might include commonly used drugs like Dexamethasone, Cytarabine, Cyclophosphamide, Fludarabine, and treatments like Calquence or IMBRUVICA, depending on what the doctors decide is best for your treatment plan within the study. You might also receive medicines for side effects, such as Panadol.

Your participation would involve regular visits to the hospital or clinic. During these visits, you would have blood tests, scans, and physical examinations to closely monitor your health, how the treatment is working, and to check for any side effects. You might also be asked to fill out questionnaires about how you are feeling to assess your quality of life. The total length of the study and how long you would need to be followed up for will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment that isn't yet widely available, which could help your condition. However, there are also potential risks involved. New treatments can have side effects that might be unknown or more severe than standard treatments. The study doctors and nurses will closely monitor you for any side effects and manage them as best as possible. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
France
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Unverified
Spain
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Unverified
Germany
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Unverified
Netherlands

Common questions

What is Mantle Cell Lymphoma?

It's a type of cancer that starts in your white blood cells, specifically a type called B cells, which are part of your immune system.

What does 'relapsed/refractory' mean?

Relapsed means your cancer has come back after treatment. Refractory means your cancer didn't respond to previous treatments, or it continued to grow despite treatment.

What is a 'Phase 2' study?

In a Phase 2 study, researchers are mainly looking at how well a new treatment works and also checking its safety. It follows earlier studies that confirm the treatment is safe enough to test on more people.

What is KTE-X19?

KTE-X19 is a new investigational treatment. The study is trying to find out more about how it works and if it can help people with Mantle Cell Lymphoma.

Will I receive other treatments too?

Yes, alongside KTE-X19, you might also receive a combination of other standard medicines that are part of the study's treatment plan.