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

A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL

This study is an early investigation into a new potential medicine, JNJ-67856633, for people living with Non-Hodgkin lymphoma and chronic lymphocytic leukemia, which are types of blood cancer. It's the very first time this drug is being given to people, so the research team will be paying close attention to its safety. They also want to understand how the medicine works in the body, including how much of it gets into the blood and how long it stays there, as well as what effects it has on the cancer cells. This type of early study is crucial in developing new treatments, but it's important to remember that it's focused on understanding the drug's basic properties.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Janssen Cilag International

Enrolment target

Start

22 Jul 2024

Non-Hodgkin lymphoma and chronic lymphocytic leukemia

What is this study about?

This study is a very early stage trial, often called a 'Phase 1' study. It's the first time the new medicine, JNJ-67856633, will be given to people. The main purpose is to carefully check if the medicine is safe and to understand how it behaves in the body. Researchers will be looking at how the medicine is absorbed, how it moves around, and how quickly the body gets rid of it. They also want to see if it has any effect on the diseases being studied.

The conditions being looked at are Non-Hodgkin lymphoma and chronic lymphocytic leukemia. These are both types of cancer that affect blood cells. Non-Hodgkin lymphoma starts in white blood cells called lymphocytes, which are part of the body's immune system. Chronic lymphocytic leukemia is a slow-growing cancer that also affects lymphocytes, specifically a type called B cells.

Because this is a very early study, it's not primarily designed to see if the medicine can cure these cancers, but rather to gather important information about its safety and how it works. This information is absolutely vital before the medicine can be tested in larger groups of people to see how well it treats these conditions. Every new medicine starts with these careful, small-scale studies to ensure patient safety.

Key takeaways

This is a very early (Phase 1) study of a new medicine, JNJ-67856633.
It's the first time this medicine is being given to people.
The study is for people with Non-Hodgkin lymphoma or chronic lymphocytic leukemia.
The main goals are to check the medicine's safety and how it works in the body.
This study is not primarily designed to cure cancer, but to gather vital initial information.

Who may be eligible?

To be able to take part in this study, you must be 18 years old or older. The study is open to both men and women. There will be other specific medical conditions and test results that you need to meet to be eligible for this study, which your doctor and the study team will review carefully.

Generally, participants will have either Non-Hodgkin lymphoma or chronic lymphocytic leukemia, as these are the specific conditions this new medicine is being investigated for. The study team will need to make sure your overall health is suitable for participating in a trial of a new medicine.

It's important to remember that not everyone with these conditions will be able to join. There are often very strict rules about who can take part to keep participants safe and make sure the study results are clear. Your own doctor and the study team will be the best people to tell you if you might be a good fit.

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 Non-Hodgkin lymphoma or chronic lymphocytic leukemia?
Are you able to attend regular clinic visits and tests?
Are you willing to follow all study instructions carefully?
Are you generally in a condition where your doctor thinks you could safely take part in a study like this?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first undergo a thorough screening process to ensure you meet all the necessary requirements. This might include medical exams, blood tests, and other assessments. Once accepted, you would receive the study medicine, JNJ-67856633. As this is an early-stage study, you can expect frequent visits to the study clinic. During these visits, the research team will closely monitor your health, conduct various tests (like blood tests and physical exams), and ask about any side effects you might be experiencing. The exact number of visits, assessments, and the full duration of your participation, including any follow-up after stopping the medicine, would be explained in detail by the study team. They will also tell you about the specific way the medicine will be given.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you would be among the first to receive this new investigational medicine, which might offer a new treatment option for your condition if other treatments haven't worked or are not suitable. However, because this is the first time this medicine is being given to people, there's a risk of unknown side effects. The study team will monitor you very closely for any reactions. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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
Greece

Common questions

What is a 'Phase 1' study?

A Phase 1 study is the first step in testing a new medicine in people. Its main goals are to check if the medicine is safe, find out what dose might be best, and understand how the medicine works in the body.

What kind of conditions is this medicine for?

This study is looking at a new medicine for people who have Non-Hodgkin lymphoma or chronic lymphocytic leukemia, which are both types of blood cancer.

Will this medicine cure my cancer?

This early study isn't designed to find a cure. Instead, it aims to gather important information about the safety of the new medicine and how it behaves in the body. If it proves safe, it can then be studied further to see how well it treats these conditions.

What is JNJ-67856633?

JNJ-67856633 is the name researchers have given to the new medicine being tested in this study. It's designed to block something called MALT1, which is a protein that can be involved in cancer growth.

Can anyone with these conditions join?

No, not everyone. There are strict rules about who can join to make sure the study is safe and that the results are clear. Your doctor and the study team will check if you meet all the specific requirements.