Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A phase I/II, multicenter study evaluating the feasibility, safety, and efficacy of point-of-care manufactured GLPG5101 (19CP02) in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma

This research study is looking at a new treatment called GLPG5101 for adults with B-cell non-Hodgkin lymphoma. This type of cancer affects white blood cells. The study is for people whose cancer has returned after treatment (relapsed) or hasn't responded to previous treatments (refractory). This is an early-stage study, meaning it's one of the first times this treatment is being tested in humans. The main goals are to find out if GLPG5101 is safe, what side effects it might cause, and if it can shrink or stop the cancer from growing. Researchers will also look at how long any cancer improvements last and overall health. The study involves different phases to gather this important information.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Lakefront Biotherapeutics

Enrolment target

160

Start

16 Dec 2022

Relapsed/refractory B-cell non-Hodgkin lymphoma

What is this study about?

This study is about a new treatment called GLPG5101 for a type of cancer called B-cell non-Hodgkin lymphoma. This is a cancer that starts in certain white blood cells and can affect different parts of the body, like lymph nodes, bone marrow, and the spleen. The study is specifically for people whose cancer has either come back after previous treatment, or hasn't improved with the treatments they've already had.

The main aim of this research is to see if the new treatment, GLPG5101, is safe for people to take. Safety is the first and most important thing to understand with any new medicine. Researchers will be very carefully looking for any side effects the treatment might cause. Another key part of the study is to see if GLPG5101 actually helps to fight the cancer. This means checking if it can make the cancer shrink, disappear, or stop it from growing for a period of time.

This study is being done in two parts, or 'phases'. In the first phase, they'll be mainly focused on safety and finding the right dose. In the second phase, once they understand the safety better, they'll look more closely at how effective the treatment is. They'll follow patients for up to two years to see how the cancer responds and how people's health changes over time, including their quality of life. This kind of research is vital for finding new ways to treat serious illnesses.

Key takeaways

This study is testing a new treatment, GLPG5101, for B-cell non-Hodgkin lymphoma.
It's for people whose cancer has returned or didn't respond to previous treatments.
The main goals are to check the treatment's safety and effectiveness.
Participants will be closely monitored for side effects and cancer response.
The study will follow participants for up to two years to understand long-term effects.

Who may be eligible?

To join this study, you must be an adult aged 18 years or older. There is no upper age limit, meaning older adults can also take part.

This study is for both men and women.

The most important medical requirement is that you have B-cell non-Hodgkin lymphoma that has either come back after past treatments or has not responded to other treatments given previously.

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 B-cell non-Hodgkin lymphoma?
Has your cancer come back after previous treatment?
Has your cancer not responded to treatments you've already had?
Are you willing to attend regular hospital visits and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the investigational treatment, GLPG5101. The study will involve a number of clinic visits where doctors will monitor your health very closely. They will likely take regular blood samples, perform scans, and ask you questions about how you are feeling to check for any side effects and see how the treatment is working. You will be followed up for up to two years after receiving the treatment to understand its long-term effects. The exact number of visits and tests will be explained to you by the study team.

Potential risks and benefits

Participating in this study might offer a chance to try a new treatment for your cancer if other options haven't worked. However, there are no guarantees that the treatment will help you, and like all medicines, GLPG5101 could cause side effects, some of which might be serious. The study team will explain all known and possible side effects to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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
Netherlands
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Unverified
Belgium
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Unverified
Finland

Common questions

What is B-cell non-Hodgkin lymphoma?

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

What does 'relapsed/refractory' mean?

It means your cancer has either come back after you've had treatment, or it hasn't responded to previous treatments you've received.

What is GLPG5101?

GLPG5101 is the name of the new treatment being tested in this study.

What is 'Phase I/II'?

This means it's an early-stage study. Phase I focuses on safety, and Phase II looks at how well the treatment works, usually after safety has been checked.

Will I get paid for joining?

Clinical trials usually do not pay participants directly, but sometimes travel expenses and other costs related to your participation might be covered. You should ask the study team about this.