Multicenter, Randomized Phase II Study of Epcoritamab for Patients With Aggressive B-Cell Lymphomas Achieving a Partial Response After CD19-Directed CAR-T Therapy
Academic and Community Cancer Research United
Summary
This phase II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.
Description
PRIMARY OBJECTIVE: I. To compare complete response (CR) rate using the Lugano 2014 criteria for patients receiving epcoritamab versus observation alone in patients with aggressive B-cell lymphomas who achieved partial response (PR) post CAR-T therapy. SECONDARY OBJECTIVES: I. To compare the progression free survival (PFS) of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T. II. To compare event free survival (EFS) in patients who receive epcoritamab determined by Lugano 2014 versus observation alone in patients with aggr…