Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients with Relapsed/ Refractory Aggressive Mature B-cell Neoplasms

This research study is testing a new drug called epcoritamab (also known as GEN3013) in children and young people. The study focuses on those who have aggressive B-cell non-Hodgkin lymphoma or similar blood cancers that have either returned after treatment or haven't responded to previous therapies. It's a Phase 1b trial, which means it's an early-stage study primarily designed to understand the drug's safety and how well patients tolerate it. Scientists will also be looking closely at how the body processes the medication and checking for any specific side effects like cytokine release syndrome (CRS) or neurological issues. Ultimately, the hope is to find a new, effective treatment for these challenging cancers in young patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

AbbVie Deutschland GmbH & Co. KG, AbbVie Deutschland GmbH & Co. KG

Enrolment target

Start

14 Nov 2023

Relapsed/Refractory Aggressive Mature B-cell Neoplasms

What is this study about?

This study is all about trying a new medicine called epcoritamab. It's for children and young people who have a certain type of aggressive blood cancer called 'mature B-cell neoplasm.' This is when the cancer cells are a specific kind of immune cell (B-cells) that have become aggressive. The 'relapsed/refractory' part means the cancer has either come back after treatment or hasn't responded to the treatments given so far. Finding new options for these situations is very important.

The main aim of this study is to find out if epcoritamab is safe to use in children and how well their bodies cope with it. Because it's a new medicine, particularly in younger patients, doctors need to be very careful. They will be watching closely for any side effects, especially things like 'cytokine release syndrome' (CRS) which is when the immune system overreacts, or 'immune cell-associated neurotoxicity syndrome' (ICANS) which can affect the brain and nervous system. They will also look at how the body uses and gets rid of the medicine.

Even though safety is the main focus, the doctors will also be gently looking to see if the medicine helps shrink the cancer. They'll check things like how long patients stay free of the cancer, how long they live, and if the treatment helps prepare them for other important treatments like a stem cell transplant. This research is a crucial step in trying to develop better ways to treat these difficult cancers in young people.

Key takeaways

This study is for children and young people with aggressive blood cancer that hasn't responded to other treatments.
It's testing a new medicine called epcoritamab to see if it's safe and how the body copes with it.
Safety is the main focus, with close monitoring for any side effects.
Participants will have regular medical check-ups and blood tests.
There's a chance to access a new treatment, but also potential risks, which will be fully explained.

Who may be eligible?

This study is open to both boys and girls of all ages. Doctors will decide if a child or young person is suitable based on their specific health situation and type of cancer.

Generally, participants will have a type of aggressive blood cancer called 'mature B-cell neoplasm' that has either come back after treatment or hasn't responded to earlier treatments. This study is for children and young people where current standard treatments might not be working.

The medical team will carefully review each potential participant's health records to ensure the study is the right fit and as safe as possible for 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, or is the child, of any age?
Do you, or does the child, have an aggressive B-cell blood cancer?
Has the cancer returned after treatment or not responded to previous treatments?
Are there no other standard treatment options currently working well?
Are you comfortable with regular hospital visits and monitoring?

Answer every question to see your result.

What does participation involve?

If you or your child takes part in this study, you would receive the new medicine, epcoritamab. It's given as a single treatment, meaning you won't be comparing it to a dummy drug or another active medicine. Doctors will explain exactly how the medicine is given.

Throughout the study, there will be regular visits to the hospital for checks. During these visits, doctors and nurses will monitor your health very closely. This will include blood tests to see how the medicine is working and to check for any side effects. You might also have other tests, like scans, to see how the cancer is responding. The medical team will also ask detailed questions about how you or your child is feeling.

The full duration of participation, including regular follow-up appointments after the main treatment period, will be clearly explained by the study team. It's important to know that these check-ups are essential for understanding the medicine's long-term effects and if the cancer stays away.

Potential risks and benefits

Potential benefits of joining this study include getting early access to a new medicine that might help treat a challenging cancer, especially if other treatments haven't worked. While there's no guarantee the medicine will work for everyone, it could offer a new treatment option. As with any medicine, there are potential risks and side effects. For this drug, doctors are particularly looking out for things like a strong immune reaction called cytokine release syndrome (CRS) or effects on the brain and nervous system (ICANS). The study team will explain all known and potential risks in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (6)

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

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Unverified
Italy
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Unverified
Germany
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Unverified
Czechia
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Unverified
Spain
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Unverified
France
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Unverified
Belgium

Common questions

What kind of cancer is this study for?

This study is for children and young people with a type of aggressive blood cancer called 'mature B-cell neoplasm' that has come back or not responded to previous treatments.

What is the new medicine called?

The new medicine being tested is called epcoritamab (also known as GEN3013).

What is the main goal of the study?

The main goal is to find out if the new medicine is safe and how well patients tolerate it, as well as how the body handles it.

Will I get regular checks if I join?

Yes, if you join, you will have regular visits and tests to monitor your health and how you respond to the medicine.

Can I leave the study if I change my mind?

Absolutely. You can choose to leave the study at any time, and this will not affect your future medical care.