This phase I trial studies the side effects of nivolumab and Epstein Barr virus specific T-cells in treating participants with Epstein-Barr virus (EBV) positive lymphoma that has come back or does not respond to treatment. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Cancer cells that are infected by EBV are able to hide from the body's immune system and escape destruction. Special white blood cells called Epstein Barr virus specific T-cells (T cells that have been trained to kill cells infected by EBV) can survive in the blood and affect the tumor. Giving nivolumab and Epstein Barr virus specific T-cells may work better in treating participants with relapsed or refractory EBV-positive lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02973113.
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of combining nivolumab with autologous Epstein-Barr virus-specific cytotoxic T lymphocytes (Epstein Barr virus specific T cells [EBVSTs]).
SECONDARY OBJECTIVES:
I. To evaluate objective response to combination nivolumab and EBVSTs by Deauville criteria.
EXPLORATORY OBJECTIVES:
I. To determine the survival and the immune function of EBVSTs when used in combination with nivolumab.
OUTLINE:
Participants receive nivolumab intravenously (IV) over 60 minutes on day 0 and then every 2 weeks for a total of 4 doses in the absence of disease progression or unacceptable toxicity. Participants also receive EBVST cells IV over 2-10 minutes on days 1 and 15. Participants with stable disease or a partial response at week 8 may receive up to 3 additional infusion of EBVST cells preceded by 1 dose of nivolumab a day prior at 6-12 weeks intervals starting at least 6 weeks after section infusion.
After completion of study treatment, participants are followed up at 3, 6, 9, and 12 months.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorHelen Elisabeth Heslop