Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study to learn how safe and tolerable odronextamab and cemiplimab are in adult patients with B-cell malignancies

This study is investigating a new treatment for adults who have a type of blood cancer called B-cell non-Hodgkin lymphoma. The new treatment involves two medicines called odronextamab and cemiplimab. This is a very early stage of research, meaning it's the first time these specific medicines are being given to people to treat this condition. The main goal is to check how safe these medicines are for patients and what kinds of side effects they might cause. Researchers also want to understand how well people tolerate the treatment. This kind of early study is important to see if a new treatment has the potential to help patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

Start

25 Mar 2024

B-Cell Non-Hodgkin’s Lymphoma (B-NHL)

What is this study about?

You might have heard about clinical trials, which are research studies that test new ways to treat illnesses. This particular study is looking into a new treatment approach for adults who have a type of blood cancer affecting B-cells. These cancers are grouped under the name B-cell non-Hodgkin lymphoma. The treatment involves two new medicines, odronextamab and cemiplimab.

This is a 'Phase I' or 'Human Pharmacology' study. Think of it as the very first step in testing a new medicine in people. Because it's so early, the main things the doctors want to find out are how safe these medicines are when given to people and how well patients' bodies cope with them (this is called 'tolerability'). They will be carefully watching for any side effects and how people feel during the treatment.

While this study won't tell us if the treatment can cure the cancer, it's a crucial first step. If these early tests show the medicines are safe enough, and patients tolerate them reasonably well, then bigger studies can be done later to see how effective they are at treating the cancer. Every new medicine we have today started with studies just like this one.

Key takeaways

This study is testing new medicines for B-cell non-Hodgkin lymphoma.
It's an early-stage study, focusing on safety and how well patients tolerate the treatment.
Adults aged 18 and over, both men and women, with this type of cancer may be eligible.
Participation involves regular hospital visits for treatment and check-ups.
You won't have to pay to participate.
You can leave the study at any time if you wish.

Who may be eligible?

This study is looking for adult patients who have a type of blood cancer called B-cell non-Hodgkin lymphoma. To be considered, you must be at least 18 years old – there is no upper age limit for joining.

Both men and women are welcome to take part in this research. The doctors will also check other things about your health to make sure it's safe for you to join the study. These will likely include checking your general health and that your body's organs (like your heart, liver, and kidneys) are working well enough.

Because this is a very early study, there will be strict rules about who can and cannot join. This is to keep everyone safe and to make sure the results are clear. Your doctor will be able to tell you if this study might be a good fit for you based on all your individual health details.

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 a diagnosis of B-cell non-Hodgkin lymphoma?
Are you able to attend regular hospital appointments?
Are you willing to follow the study's treatment plan and assessments?
Have you discussed your cancer treatment options with your doctor?

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 medicines, odronextamab and cemiplimab, as part of your treatment. The study doctors and nurses would carefully monitor you throughout. This would involve regular visits to the hospital or clinic.

During these visits, you would have various assessments. These might include physical examinations, blood tests to check your health and how the medicines are affecting your body, and possibly other scans or tests related to your cancer. The exact number of visits and tests would be explained to you in detail by the study team.

After you finish receiving the treatment, there would likely be a follow-up period. This means you would still have some check-ups for a certain amount of time to see how you are doing and to collect more information about the medicines. The total amount of time you would be involved in the study, from starting treatment to the end of follow-up, would be clearly explained to you by the study team.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that you would receive a new, experimental treatment for your B-cell non-Hodgkin lymphoma, which might otherwise not be available. You would also be contributing to medical research that could help future patients. However, because these are new medicines, there's a risk of unknown side effects or that the treatment may not help your condition. The study medicines might also cause side effects that are already known, which your doctor will explain. It's very important to remember that you have the right to leave 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.

—
Unverified
Spain
—
Unverified
Austria
—
Unverified
Poland

Common questions

What is B-cell non-Hodgkin lymphoma?

It's a type of cancer that starts in certain white blood cells called B-cells, which are part of your immune system. It can affect many parts of the body.

What does 'Phase I' study mean?

It means this is one of the very first times these new medicines are being given to people. The main focus is on safety and how well people tolerate the treatment, rather than its effectiveness.

Will I get better if I join this study?

This study's main goal is to check safety. While some people might feel better, there's no guarantee the treatment will improve your condition. It's too early to know how effective it is.

Will I have to pay to be in the study?

No, you should not have to pay for the study medicines or any study-related tests or appointments. Your travel costs might even be covered, but you should confirm this with the study team.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without needing to explain why. It won't affect your future medical care.