Subcutaneous Epcoritamab Plus Lenalidomide Compared With R-GemOx for Relapsed/Refractory DLBCL

B-cell lymphoma is a fast-growing and uncommon cancer that affects white blood cells, which normally help the body fight infections. This study is looking at how safe and how well different treatment options work for adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has come back or did not respond to treatment.

The study compares a newer treatment combination called epcoritamab plus lenalidomide with a standard treatment called rituximab plus gemcitabine and oxaliplatin. Researchers will monitor side effects and see how each treatment affects the cancer.

Epcoritamab is a study drug that is still being tested and is not yet approved for all uses. Participants are placed into one of the following three treatment groups by chance:

• Group A will receive injections of epcoritamab under the skin and take lenalidomide capsules by mouth for up to 12 treatment cycles (each cycle lasts 28 days).
• Group B will receive rituximab, gemcitabine, and oxaliplatin through a vein (IV) for up to 4 treatment cycles.
• Group C will receive injections of epcoritamab under the skin for up to 12 treatment cycles.

Taking part in this study may require more time and clinic visits than usual care. Participants will have regular visits to the hospital or clinic for exams, blood tests, checks for side effects, and questionnaires to understand how they are feeling during treatment.

In order to participate you must meet the following criteria:

• Are 18 years of age or older.
• Have a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) or a closely related type of B-cell lymphoma that tests positive for a marker called CD20.
• Have lymphoma that has come back or did not respond to previous treatment.
• Have already received at least one prior cancer treatment, including chemotherapy that contained an anti-CD20 medicine.

In addition, participants must meet at least one of the following conditions:

• Their lymphoma returned after a stem cell transplant or did not respond to a stem cell transplant.
• They cannot have a stem cell transplant because of age, overall health, other medical conditions, limited response to past treatment, or they chose not to have one.
• They are not eligible for CAR-T cell therapy or are unable to receive it.

You will be excluded from the study if any of the following criteria apply to you:

• Have already been treated with certain similar cancer medicines, including R-GemOx, GemOx, or a bispecific antibody that targets CD3 and CD20.
• Have received lenalidomide within the past 12 months, or your cancer did not respond to lenalidomide in the past.
• Have had CAR-T cell therapy within the last 90 days.
• Are unable to tolerate SC injections or swallow capsules.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.