Active not recruitingPHASE1INTERVENTIONAL

A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)

This study is looking at new treatments for a type of blood cancer called B-Cell Non-Hodgkin Lymphoma. This is for people whose lymphoma has either come back after treatment or hasn't responded to previous treatments. The study is in its early stages (Phase 1) and aims to test new combinations of two drugs, JNJ-80948543 and JNJ-75348780. The main purpose is to figure out the safest and most effective dose of these drug combinations to use in future studies. Researchers will also be checking carefully for any side effects. This early research is crucial for developing new ways to fight this type of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Janssen Research & Development, LLC

Enrolment target

Start

22 Oct 2024

Estimated completion

21 Sep 2026

Lymphoma, Non-Hodgkin

What is this study about?

This research study is about finding better ways to treat a specific type of blood cancer called B-cell Non-Hodgkin Lymphoma. This is a cancer that starts in certain white blood cells. This study is specifically for people where the cancer has either returned after earlier treatments or hasn't gone away after previous treatments. This is called 'relapsed/refractory' lymphoma.

The study is testing two new medications, known by their study codes JNJ-80948543 and JNJ-75348780. These drugs are designed to help your body's immune system fight the cancer cells. This is an early-stage study, called 'Phase 1'. This means it's one of the first times these specific combinations of drugs are being tested in people. The main goal is to find out what dose of these drugs works best and is safest to use together. Researchers will also be closely watching for any side effects.

Finding a safe and effective dose is a really important step in developing new treatments. If this step is successful, it could lead to further studies that might eventually offer new options for people with this type of lymphoma. This research aims to contribute to developing more effective therapies for those who need them.

Key takeaways

This study is for a type of blood cancer called B-Cell Non-Hodgkin Lymphoma.
It's for people whose cancer has returned or hasn't responded to previous treatments.
The study is testing new combinations of two medications.
The main goal is to find the safest and most effective dose of these new drugs.
This is an early-stage research study (Phase 1).
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

To be able to join this study, you would generally need to have a specific type of B-cell Non-Hodgkin Lymphoma called diffuse large B-cell lymphoma (DLBCL), and it must have come back or not responded to at least two previous treatments. Doctors would also need to be able to measure your cancer, and you should be generally well and able to carry out most daily activities.

There are also some reasons why you might not be able to join. For example, if your cancer has spread to your brain or spinal cord, or if you've already had an organ transplant. You also can't have certain other serious health problems like uncontrolled infections or severe lung issues needing extra oxygen. Any side effects from your past cancer treatments should have mostly cleared up before you start.

Quick self-check

Do I have diffuse large B-cell lymphoma (DLBCL)?
Has my lymphoma come back or not responded to at least two previous treatments?
Do I have cancer that doctors can measure with scans?
Am I generally well enough to go about most of my daily activities?
Do I currently have any serious infections or lung problems that need extra oxygen?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be given one of the two study medications, JNJ-80948543 or JNJ-75348780, or a combination of both. You will have regular visits to the hospital or clinic for assessments, which will include blood tests, scans, and physical examinations to see how you are responding to the treatment and to check for any side effects. The medications will be given to you by injection or infusion. The exact schedule of visits and treatments will depend on which part of the study you are in, but it will involve frequent check-ups, especially in the beginning. You will also have follow-up appointments after your treatment period ends to continue monitoring your health. The total duration of your participation will vary depending on your individual response and the study's design.

Potential risks and benefits

Like all medical treatments, there are potential benefits and potential risks to consider. The potential benefit is that these new drug combinations might help treat your lymphoma where other treatments haven't worked. However, because this is an early-stage study, we don't yet know how effective these drugs will be, and there may be side effects, some of which could be serious. You will be closely monitored for any reactions. It's very important to remember that participating in any clinical trial is always your choice, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Concord Hospital
Concord, Australia
St Vincents Hospital Melbourne
Fitzroy, Australia
Macquarie University Hospital
North Ryde, Australia
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp. Clinic de Barcelona
Barcelona, Spain
Inst. Cat. Doncologia-H Duran I Reynals
L'Hospitalet de Llobregat, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
China Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
University Hospitals Of Leicester Nhs Trust
Leicester, United Kingdom

Common questions

What is Non-Hodgkin Lymphoma?

Non-Hodgkin Lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of your body's immune system. B-cell lymphoma is a specific type of Non-Hodgkin Lymphoma.

What does 'relapsed/refractory' mean?

This means your cancer has either come back after you've been treated for it (relapsed) or it hasn't responded well to previous treatments (refractory).

What does 'Phase 1' mean for a study?

Phase 1 is the earliest stage of human testing for a new drug. The main goal is to find a safe dose and see what side effects might occur.

What are CD3 T-Cell Engagers?

These are types of drugs designed to help your own immune system (specifically T-cells) find and kill cancer cells more effectively.

Will I have to pay to be part of the study?

No, you will not have to pay for the study drugs or any of the medical care related to the study.