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

A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants with NHL and CLL

This research study is looking at a new medicine called JNJ-75348780. This medicine is designed for people who have specific types of blood cancers: B-cell Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL). These are cancers that have either come back after treatment or haven't responded to previous treatments. It's a very early-stage study, meaning it's the first time this particular medicine is being tested in people. The main goal is to find out if the medicine is safe, what effects it has on the body, and to determine the best dose to use in future studies. This kind of early research is crucial for developing new treatments for serious illnesses.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Janssen - Cilag International

Enrolment target

Start

01 Jul 2024

Relapsed/refractory B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

What is this study about?

This study is about a new medicine, which we'll call JNJ-753, for short. Doctors are hoping JNJ-753 could help people who have certain types of blood cancer. These cancers are called B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). The study is for people whose cancer has either returned after being treated before (we call this 'relapsed') or hasn't responded to other treatments (we call this 'refractory'). It's important to remember that this medicine is still in its very early testing stages.

This early stage is called a 'Phase 1' study. In Phase 1 studies, the main aim is to carefully check if a new medicine is safe for people. Doctors also want to understand how the medicine works in the body and to find the right amount, or 'dose', to give to patients. Because it's the first time JNJ-753 is being given to humans, the research team will start with very small doses and gradually increase them, all while closely monitoring the participants.

Learning about new medicines like JNJ-753 is a vital step in finding better ways to treat serious conditions like lymphoma and leukaemia. By taking part in studies like this, patients help doctors understand if a new treatment could be effective and safe for many more people in the future. It helps advance medical science and potentially offers new options for those who need them most.

Key takeaways

This study is testing a brand-new medicine for specific blood cancers.
It's a 'first-in-human' study, focusing on safety and finding the right dose.
It's for adults with lymphoma or leukaemia that has returned or not responded to prior treatment.
Participation involves regular hospital visits for treatment and monitoring.
Potential benefits include access to a new medicine; potential risks include unknown side effects.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part in this research.

Crucially, this study is specifically for individuals diagnosed with B-cell Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL). Your cancer must also have either returned after previous treatment or not responded well to other treatments you've had in the past.

The research team will have other specific health checks to make sure this study is right for you and safe. These checks are important to protect your health while you are, taking part, and they will be explained fully by the study doctors.

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 (NHL) or Chronic Lymphocytic Leukemia (CLL)?
Has your cancer come back after treatment, or hasn't it responded to previous treatments?
Are you able to attend regular hospital visits for treatment and checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have several screening tests to make sure the study is suitable for you. If you qualify, you would receive the new medicine, JNJ-753, on a set schedule. This would involve regular visits to the hospital or clinic for treatments and check-ups.

During these visits, the study team would carefully monitor your health. This includes taking blood samples, conducting physical exams, and possibly performing other tests like scans to see how your body is responding to the medicine. You would be asked questions about how you feel and any side effects you might be experiencing.

The total length of time you would be involved in the study can vary. It usually involves a period of taking the medicine, followed by a follow-up period where you're still monitored after you stop taking the medicine. All the details, including the exact schedule of visits and tests, would be explained to you before you agree to participate.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of accessing a new treatment that isn't yet widely available, which could help if your cancer hasn't responded to other treatments. However, because this is an early study, the main goal is to understand safety. There's no guarantee the medicine will help your cancer. As with any medicine, there are potential risks, including side effects that are not yet fully known. The study team will explain all known and potential 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 (2)

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

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Unverified
Spain
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Unverified
France

Common questions

What kind of new medicine is JNJ-753?

It's a special type of medicine called a 'bispecific antibody' that is designed to target specific cells in your body involved in cancer.

Why is this study only for people whose cancer has come back or not responded to treatment?

This allows researchers to test new medicines in situations where current treatments haven't been fully effective, offering a potential new option.

How long might I need to be in the study if I take part?

The exact length varies for each person, but you would be involved for the treatment period and then a follow-up period to check your health. All this will be discussed in detail.

Will I know if I'm getting the actual medicine or a dummy treatment?

In this specific Phase 1 study, all participants who receive treatment will be given the actual new medicine, JNJ-753. There is no 'dummy' treatment (placebo) used for comparison.

Can I continue with my regular medications if I join the study?

That depends on your specific medications and the study rules. You must tell the study doctors about all medicines you are taking, so they can advise you on what is safe.