A Phase I Study of REGN1979 in Patients with CD20-Positive B-Cell Cancers Previously Treated with CD20-Directed Antibody Therapy

Full Title

An Open-label, Multi-center Phase I Study to Investigate the Safety and Tolerability of REGN1979, An Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients with CD20+ B-Cell Malignancies Previously Treated with CD20-directed Antibody Therapy

Purpose

Drugs that target a protein called CD20, such as rituximab, are commonly used to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Despite treatment, however, the cancer often comes back or continues to grow. In this study, researchers are determining the highest dose of the investigational drug REGN1979 that can be given safely in patients with CLL or SLL that continues to grow despite prior treatment that targeted CD20.

REGN1979 is a bispecific monoclonal antibody which targets two proteins cells: CD20 and CD3. CD20 is found on the surface of normal B cells and on the B cells in some cancers like CLL and SLL. CD3 is found on the surface of immune cells called T cells. REGN1979 helps T cells find and kill B cells, including CLL and SLL cancer cells. REGN1979 is given intravenously (by vein).

Eligibility

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

  • Patients must have CLL or SLL that has come back or continued to grow despite CD20-directed antibody therapy.
  • Patients should recover from the serious side effects of prior treatments before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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 212-639-8596.

Protocol

18-430

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators