drugset / Trial / NCT00706316

Administration of Epstein Barr Virus - Specific Cytotoxic T-Lymphocytes to Metastatic EBV-Positive Nasopharygneal Cancer

NCT00706316 ↗

Phase 1 Completed 5 enrolled University Health Network, Toronto
NaSingle-groupOpen-label

Summary

Nasopharyngeal cancer (NPC) is a cancer that starts at the back of the nose. Without distant spread, NPC is sensitive to radiotherapy and chemotherapy; however, if NPC relapses or spreads to other organs, treatment options are limited. This grant proposes to evaluate the safety and tolerability of a novel treatment for patients with NPC that has either relapsed or spread to distant organs. Epstein-Barr Virus (EBV) is known to play a role in the development of NPC, and studies have shown that NPC tumor cells express proteins that are related to EBV. Some of these proteins can trigger a response from the immune system, specifically the activation of cytotoxic T lymphocytes (CTLs), a type of immune cell that might exert anti-tumor effects. In this project, we will take blood from NPC patients, generate CTLs targeted against EBV, and re-infuse these back into patients in an attempt to achieve anti-tumor activity. Patients will also receive an antibody called CD45 Mab prior to CTL infusion in order to allow for better expansion of the infused CTLs in the patients.

Timeline

Start
2007-12
Primary completion
2009-08
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject EBV specific CTLs Cell therapy 5e+07 unknown Intravenous
Subject EBV specific CTLs Cell therapy 1e+08 unknown Intravenous
Subject EBV specific CTLs Cell therapy 2e+08 unknown Intravenous
Background CD45 Mab Monoclonal antibody — Intravenous