A Phase I Study of Epcoritamab in People with Relapsed or Persistent Chronic Lymphocytic Leukemia

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Full Title

A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013 DuoBody-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia

Purpose

The purpose of this study is to find the highest dose of the investigational drug epcoritamab that can be given safely in patients with chronic lymphocytic leukemia (CLL) that has come back or continued to grow despite prior treatment.

Epcoritamab is a type of drug called a bispecific antibody, which is designed to attach to two different proteins at one time. Epcoritamab binds to CD20, a protein on the surface of cancer cells, and another protein called CD3 which is found on the surface of immune cells called T cells. When epcoritamab attaches to CD3 and CD20 at the same time, it activates T cells to kill cancer cells. It is given as a subcutaneous (under the skin) injection.

Eligibility

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

  • Patients must have CLL that came back or continued to grow despite at least two prior regimens of therapy.
  • At least 2 weeks must pass since the completion of prior chemotherapy or radiation therapy and 4 weeks since prior antibody therapy or CAR T-cell therapy and receipt of epcoritamab.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Anthony Mato at 646-608-3748.

Protocol

21-072

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator