Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
This research study is looking at a new medicine called epcoritamab (also known as EPKINLY™) for people who have a type of blood cancer called B-cell non-Hodgkin lymphoma (B-NHL), specifically Diffuse Large B-Cell Lymphoma or Follicular Lymphoma. Doctors want to find out if epcoritamab is safe and how well it works, either on its own or when combined with other common cancer treatments. They will also find the best dose to use. Everyone taking part will receive the active medicine, with no placebo given. The treatment is given as an injection under the skin, and some people may also receive other standard treatments, which could be given into a vein or as tablets.
At a glance
What is this study about?
This study is designed to learn more about a new medicine called epcoritamab, sometimes known as EPKINLY™. This medicine is for people who have B-cell non-Hodgkin lymphoma (B-NHL), which is a type of cancer that starts in certain white blood cells. Specifically, the study is looking at two types: Diffuse Large B-Cell Lymphoma and Follicular Lymphoma. The main goals are to find out if epcoritamab is safe and how well it helps to treat the cancer when given alone or with other standard cancer medicines.
The study has two main parts. The first part is to find the best and safest dose of epcoritamab to use. Once that dose is found, the second part will look at a larger group of people to see how well that chosen dose works. There are many different treatment groups in this study, and each group will receive epcoritamab either alone or combined with another common cancer treatment. This allows doctors to test different ways of using the new medicine to find the most effective approaches.
All participants in this study will receive the active medicine; no one will be given a dummy treatment (placebo). Epcoritamab is given as an injection just under the skin. If you are in a group that also receives other standard treatments, these might be given into a vein (like a drip) or as tablets.
Key takeaways
- The study tests a new medicine, epcoritamab, for B-cell non-Hodgkin lymphoma.
- It aims to find safe doses and how well epcoritamab works, alone or with other treatments.
- Epcoritamab is given as an injection under the skin.
- All participants receive the active medicine, no placebo.
- Visits start weekly then become less frequent.
- You can stop participating at any time.
Who may be eligible?
To join this study, people generally need to be 18 years or older and have a confirmed diagnosis of B-cell non-Hodgkin lymphoma, specifically Diffuse Large B-Cell Lymphoma or Follicular Lymphoma. Doctors will check scanned images (like CT or MRI) to ensure there is enough cancer to measure. Your overall health and how well your body's organs are working will also be checked, and you would need to be reasonably fit and able to carry out daily activities.
There are specific rules for each treatment group within the study. For example, some groups are for people who have just been diagnosed, while others are for those whose cancer has come back or hasn't responded to previous treatments. It’s important that your cancer cells also show a specific marker called CD20, as epcoritamab targets this.
Some things would prevent you from joining the study. For instance, if you've had certain cancer treatments (like chemotherapy or radiation) or major surgery very recently (within the last 4 weeks), or if you've previously had a specific type of treatment called a bispecific antibody that targets CD3 and CD20, or CAR-T therapy. If you are a woman who could become pregnant, or a man with a partner who could become pregnant, you would need to agree to use effective birth control during the study.
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 Diffuse Large B-Cell Lymphoma or Follicular Lymphoma?
- Are you generally able to carry out daily activities?
- Have you not had chemotherapy, radiation, or major surgery within the last 4 weeks?
- Have you not had a specific type of prior immune therapy (bispecific CD3/CD20 or CAR-T)?
What does participation involve?
If you join this study, the duration of your treatment will depend on which specific treatment group you are assigned to. For all participants, visits to the clinic will be weekly at the beginning. As treatment continues, these visits will become less frequent, potentially every 2, 3, 4, or even 8 weeks, depending on your treatment group.
Everyone in the study will receive the active study medicine, epcoritamab, which is given as an injection just under the skin. The exact way you receive epcoritamab (how much and how often) will vary depending on your assigned treatment group. If your treatment group combines epcoritamab with other standard cancer medicines, these might be given into a vein (like a drip) or as tablets, again depending on your specific group.
During your visits, you will have various assessments to check your health, how the treatment is working, and to monitor for any side effects. These could include blood tests, scans, and physical examinations.
Potential risks and benefits
Locations (57)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States
- Cedars-Sinai Medical CenterVerified postcodeLos Angeles, United States
- David Geffen School of Medicine at UCLAVerified postcodeLos Angeles, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- Dana Farber Cancer InstituteVerified postcodeBoston, United States
- University of Michigan Comprehensive Cancer Center Michigan MedicineVerified postcodeAnn Arbor, United States
- Hackensack University Medical CenterVerified postcodeHackensack, United States
- Mount SinaiVerified postcodeNew York, United States
- Memorial Sloan Kettering CCVerified postcodeNew York, United States
- Levine Cancer CenterVerified postcodeCharlotte, United States
- Southwestern Medical CenterVerified postcodeDallas, United States
- Austin HealthVerified postcodeHeidelberg, Australia
Common questions
What is B-cell non-Hodgkin lymphoma (B-NHL)?
It's a type of cancer that affects a specific kind of white blood cell called B cells. These cells are part of your immune system.
What is epcoritamab?
Epcoritamab is a new medicine being tested. It's designed to help your immune system find and kill cancer cells.
How will I receive epcoritamab?
Epcoritamab is given as an injection just under your skin.
Will I get a dummy treatment (placebo)?
No, everyone in this study will receive the active medicine (epcoritamab), either alone or with other treatments.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.