Assessing the Anti-Tumor Activity and Safety of REGN1979 in Patients with Relapsed or Refractory Follicular Lymphoma

Follicular lymphoma is a cancer of lymphocytes, a type of white blood cell. In follicular lymphoma, the white blood cells grow and survive longer than normal and this can cause problems such as large lymph glands, particularly in the neck, armpit, or groin areas. Some patients with follicular lymphoma develop large tumors in the abdomen.

There are limited treatment options for patients with FL that has recurred after 2 or more courses of treatment or with disease that is resistant to anti-CD20 therapy. REGN1979 is an antibody that binds to 2 proteins called CD20 and CD3.  The CD20 protein is found on the surface of B-cells, including cancerous B-cells that make up follicular lymphoma.  The CD3 protein is found on the surface of T-cells, which are also a type of white blood cell and part of the immune system.  REGN1979 is designed to help T-cells find and destroy the cancerous B-cells. The main purpose of this study is to assess the effectiveness of REGN1979 in destroying cancer cells and to learn more about the safety of REGN1979.

Participation in this study may last up to 46 months (about 3¾ years).  The study drug is given through a vein (intravenous [IV] infusion) or a central line if the participating subject has one.

In order to participate you must meet the following criteria:

• Are 18 years of age or older.
• Have received at least 2 prior treatment regimens for your FL, including an anti-CD20 antibody and an alkylating agent.
• Have adequate organ and bone marrow function.

You will be excluded from the study if any of the following criteria apply to you:

• Have had an allogeneic stem cell transplantation or prior CAR-T therapy.
• Have FL that has primary central nervous system involvement.
• Have evidence of significant heart disease or uncontrolled infection.

This is a partial list of inclusion and exclusion criteria.