PREVALE Study (H-39090)
PREVALE - Phase I Study Combining Nivolumab With Epstein Barr Virus Specific T Cells (EBVSTs) in Relapsed/Refractory EBV Positive Lymphoma Patients
Age Requirement: 0 to 65+
Subjects have a type of a lymph node cancer called Non-Hodgkin's Lymphoma (NHL) or lymphoproliferative disease (LPD), which affects their immunity, blood production, and can involve multiple other organs in the body. Their disease has come back or has not gone away after treatment. The experimental treatment plan consists of an antibody therapy called "Nivolumab" that helps the subjects' T-cells control the tumor, and special immune system cells called LMP-specific cytotoxic T lymphocytes, also a new therapy whose side effects are well studied.
Some patients with NHL or LPD are infected with the virus that causes infectious mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their diagnosis. The cancer cells that are infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called T cells, that have been trained to kill cells infected by EBV can survive in the blood and affect the tumor.
Investigators have used this sort of therapy to treat a different type of cancer that occurs after bone marrow or solid organ transplant called post-transplant lymphoma with good success. These cells are called LMP-specific cytotoxic T-lymphocytes (EB-VSTs), and are effective in treating these diseases. These LMP-specific EB-VSTs are experimental and not yet approved by the Food and Drug Administration (FDA).
Sometimes it is not possible to grow these cells; or they may not last very long in the body after being given into the vein thereby having only limited time to fight the tumor. With this study, investigators aim to increase the duration of time that the T cells can last in the body and can effectively fight the cancer by using nivolumab. Nivolumab is FDA approved for treatment of other kinds of cancer like lung cancer and a skin cancer called Melanoma.
The purpose of this study is to find out if LMP-specific EB-VST cells in combination with nivolumab are safe, to learn what the side effects are, and to see whether this therapy may help patients with EBV related lymphoma or LPD.
NCT#/ClinicalTrials.gov ID: 02973113