A Phase IA/II Study of Epcoritamab in People with B-Cell Non-Hodgkin Lymphoma

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Full Title

A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody® -CD3xCD20) in Combination with Other Agents in Subjects with B-cell Non-Hodgkin Lymphoma

Purpose

The purpose of this study is to find the highest dose of the investigational drug epcoritamab that can be given in combination with standard chemotherapy for people with B-cell non-Hodgkin lymphoma. Epcoritamab is a type of drug called a bispecific antibody, which is designed to bind to two different proteins at one time: one on the surface of cancer cells and another protein on immune cells called T cells. It is expected that this treatment can boost the immune response against lymphoma cells and, when given with standard chemotherapy, improve the results of standard chemotherapy alone. Epcoritamab has been assessed before in other clinical trials.

Patients in this study will be assigned to one of five groups depending on their type of cancer and treatment history:

  • Group 1: those with previously untreated diffuse large B-cell lymphoma (DLBCL) will receive epcoritamab together with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)
  • Group 2: patients with follicular lymphoma that has returned after chemotherapy will receive epcoritamab together with rituximab and lenalidomide
  • Group 3: those with previously untreated follicular lymphoma will receive epcoritamab together with rituximab and bendamustine
  • Group 4: patients with DLBCL that has returned after chemotherapy and who are eligible for autologous stem cell transplantation will receive epcoritamab together with rituximab, oxaliplatin, cytarabine, and dexamethasone
  • Group 5: patients with DLBCL that has returned after chemotherapy and who are not eligible for autologous stem cell transplantation will receive epcoritamab together with gemcitabine and oxaliplatin

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have non-Hodgkin lymphoma that is positive for a protein called CD20.
  • For groups 2, 4, and 5: At least 4 weeks must pass between the completion of prior anticancer therapy and receipt of the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Lorenzo Falchi’s office at 646-608-3705.

Protocol

21-164

Phase

I/II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators