A Study of the Safety and Efficacy of EBV Specific T-cell Lines

Official Title

A Phase I/II Open-label Study of the Safety and Efficacy of Epstein-Barr Virus Specific T-cell Lines for the Treatment of EBV Infection or EBV-related Lymphoproliferative Diseases

Summary:

This study evaluates the safety and efficacy of EBV-specific T-cell lines to treat patients suffering from high EBV viral titers not responding to standard of care therapies and to treat EBV-related lymphoma. The study will recruit 6 patients to receive autologous T cells or a T cell line derived from the patient's allogeneic donor (in the case of stem cell transplant recipients), and 6 patients to receive a T-cell line prepared from a matched or partially matched related donor.

Trial Description

Primary Outcome:

  • Safety: Incidence and description of CTCAE v.4.03 adverse events related to the experimental treatment
Secondary Outcome:
  • Changes in EBV titers (viral load) for each patient
  • Immune reconstitution as measured by various laboratory assays of immune cell type and function
  • All cause mortality
  • Transplant-related outcomes
  • Incidence/severity of graft-versus-host disease among patients who underwent stem cell transplantation
  • Number and severity of solid organ rejection episodes per patient among those who underwent solid organ transplant
  • Incidence of primary disease relapse among patients who underwent stem cell transplantation
  • Malignancy staging for patients with lymphoma, per internationally-accepted guidelines for the different specific lymphomas
Epstein-Barr virus (EBV) is a member of the herpes virus family and infects up to 95% of individuals over their lifetime. Most initial infections occur in childhood and after a brief flu-like illness, the virus enters a phase of latency. Patients who receive a bone marrow transplant or an organ transplant take medications drugs that weaken their immune systems. In these contexts, the virus can "reactivate" and cause very serious problems, such as lymphoma. For unknown reasons, people with a normal immune system can also develop lymphoma due to EBV. The purpose of this study is to test the safety and efficacy of immune cells (T lymphocytes) that are specifically "taught" to recognize the virus-infected cells and to eliminate them. This "education" occurs is done over during a 2 weeks period (approximately), in the research laboratory. The cells are then transfused into the patient.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society