Phase IbII Study of Epcoritamab and Ibrutinib for Adults with Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating the safety, best dose, and effectiveness of combining epcoritamab and ibrutinib to treat patients with aggressive B-cell non-Hodgkin lymphoma that has returned or not responded to previous treatments. Epcoritamab is a bispecific antibody that connects immune T cells to lymphoma B cells to help the immune system attack the cancer. Ibrutinib blocks signals that help lymphoma B cells survive and grow, and it may also improve T cell function to support epcoritamabs action. Participants take ibrutinib by mouth daily starting one week before the first treatment cycle and continuing through up to six 28-day cycles. Epcoritamab is given as a subcutaneous injection on specific days during up to 12 cycles, with treatment continuing unless disease progresses or side effects become unacceptable. Patients also undergo blood tests, CT scans, PETCT scans, and may have bone marrow samples taken during the study. After treatment ends, patients are followed every three months for two years, then every six months for up to five years. During the study, researchers monitor safety by tracking side effects and a specific immune reaction called cytokine release syndrome. They evaluate treatment response using imaging and clinical criteria, including complete and overall response rates, progression-free and overall survival, and duration of response. Blood and tumor samples are analyzed to understand immune effects, tumor environment, and disease markers. The total participation may last several years due to long-term follow-up visits.

Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma