This phase I trial studies the side effects and best dose of LMP1/BARF1/EBNA1-specific cytotoxic T-lymphocytes when given together with or without cyclophosphamide and fludarabine in treating participants with Epstein-Barr virus (EBV)-positive lymphoma. Immunotoxins, such as LMP1/BARF1/EBNA1-specific cytotoxic T-lymphocytes, are antibodies linked to a toxic substance and may help find certain cancer cells and kill them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving LMP1/BARF1/EBNA1-specific cytotoxic T-lymphocytes, cyclophosphamide, and fludarabine together may work better in treating participants with EBV-positive lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02287311.
PRIMARY OBJECTIVES:
I. To determine the feasibility and safety of administering banked allogeneic, partially human leukocyte antigen (HLA)-matched rapid EBV specific T cells (ESTs) in patients with EBV-associated Hodgkin’s disease or non-Hodgkin’s lymphoma or T/natural killer (NK)-lymphoproliferative disease and chronic active EBV infection (CAEBV).
SECONDARY OBJECTIVES:
I. To assess the anti-viral and anti-tumor effects of ESTs.
EXPORATORY OBJECTIVES:
I. To determine the survival and the immune function of EST lines.
II. To obtain preliminary information on the safety and response to an extended dosage regimen.
OUTLINE: This is a dose-escalation study of LMP1/BARF1/EBNA1-specific cytotoxic T-lymphocytes.
Participants receive LMP1/BARF1/EBNA1-specific cytotoxic T-lymphocytes intravenously (IV) on days 0 and 14. Participants who have not recently received chemotherapy and are not lymphopenic (anaplastic large cell [ALC] > 500) may receive 3 daily doses of cyclophosphamide IV over 1 hour and fludarabine IV over 30 minutes finishing at least 24 hours before T cell infusion.
After completion of study treatment, participants are followed up at 3, 6, 9, and 12 months and then yearly for up to 5 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorRayne Helen Rouce