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

Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

This research is investigating a new medication, odronextamab, for individuals diagnosed with B-cell non-Hodgkin lymphoma, a type of cancer that affects specific white blood cells. This is a very early study, known as Phase 1, which means it's one of the first times this medicine is being given to people. The main goals are to carefully check if the medicine is safe to use and to understand any side effects it might cause. It will also help doctors learn how the body reacts to this new treatment. This kind of study is crucial for understanding if a new medicine 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

08 Jul 2024

B-cell non-Hodgkin lymphoma (NHL)

What is this study about?

This study is looking at a new experimental medicine called odronextamab. It's for people who have B-cell non-Hodgkin lymphoma, which is a cancer that starts in certain white blood cells called B cells. These B cells are part of your immune system. The goal of this research is to see if odronextamab is safe to give to people and to understand if it causes any side effects. This is a very early-stage study, often called a 'Phase 1' study, which means it's one of the first times this specific medicine is being tested in humans.

When new medicines are developed, they go through different stages of testing. Phase 1 studies are mainly about safety. Doctors want to find out the right dose to give and what kind of side effects to expect. Researchers will also observe how the body handles the medicine.

Understanding the safety and tolerability of new treatments like odronextamab is a vital step in medical research. If this early study shows promising results regarding safety, it could pave the way for further research to see if odronextamab is effective in treating B-cell non-Hodgkin lymphoma.

Key takeaways

This is an early study of a new medicine for B-cell non-Hodgkin lymphoma.
The main goal is to check the medicine's safety and side effects.
Participation requires regular clinic visits and health monitoring.
You must be 18 or older to join.
You can stop participating at any time.
There's no guarantee of personal benefit from the drug.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part. The study is specifically for people who have been diagnosed with B-cell non-Hodgkin lymphoma.

There will be other important health requirements that the study doctors will need to check to make sure it's safe for you to participate. This might include checking your overall health, how well your organs are working, and any other medical conditions you might have.

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 B-cell non-Hodgkin lymphoma?
Are you able to attend regular clinic appointments?
Are you willing to follow the study's procedures and guidelines?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicine, odronextamab. You'll have regular visits to the clinic so the study team can monitor your health very closely. These visits will involve various tests, such as blood tests, physical examinations, and scans. The team will be looking out for any side effects and how your body is responding to the medicine.

The total duration of your participation in the study, including the treatment period and follow-up, will be clearly explained to you by the study team. You will have regular contact with the doctors and nurses throughout your time in the study.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that isn't widely available yet, which could potentially help your condition. However, there's no guarantee the treatment will work for you, and like all medicines, odronextamab may cause side effects, some of which could be serious or unexpected. The study team will explain all known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is B-cell non-Hodgkin lymphoma?

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

What does 'Phase 1 study' mean?

It's an early-stage study where a new medicine is given to people for the first time to check its safety and how well people tolerate it.

Will I get paid to join the study?

Clinical trials usually do not pay participants, but they may cover travel costs or expenses related to your attendance. This will be discussed with you.

Can I continue my regular medication while in the study?

The study doctors will review all your current medications to ensure they don't interfere with the study drug and will advise you on what you can take.

How long will I need to be involved in the study?

The duration of your participation will be clearly explained by the research team if you are eligible for the study.