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Completed

NCT Number: NCT02580539

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Capacity to provide informed consent
  • Age ≥ 18 years old
  • Confirmed treatment-refractory EBV reactivation or EBV-related lymphoma
  • ECOG of 2 or less

Exclusion criteria

  • Medical condition requiring a corticosteroid dose greater than Prednisone 0.5mg/kg/day (or equivalent) at the time of the infusion.
  • Patient has received T-cell depleting antibodies or stem cell transplantation in the 28 days prior to proposed date of anti-EBV T-cell line infusion
  • Patient has received a solid organ transplant in the 3 months prior to proposed date of anti-EBV T-cell line infusion.
  • Pregnant or nursing females
  • Life expectancy of less than 3 months due to a condition unrelated to the EBV- related disease.
  • Active uncontrolled GVHD
  • Active uncontrolled SOT rejection episode

DONOR ELIGIBILITY: An allogeneic donor must be a first-degree relative with at least 3/6 HLA compatibility, have consented to donate peripheral blood mononuclear cells, and fulfill the same criteria for stem cell donation according to the hospital's standard operating procedure.

Treatment and study plan

Group A

Biological

Peptide-stimulated T cells 2 x 10^7/m^2

Group B

Biological

Peptide-stimulated T cells per dose-escalation protocol

Primary outcomes

  1. Safety: Incidence and description of CTCAE v.4.03 adverse events related to the experimental treatment

    Time frame: During observation period (up to 42 days post infusion)

    Complications: infusional toxicity, immune-related and other

Secondary outcomes

  1. Changes in EBV titers (viral load) for each patient

    Time frame: Until 12 months post infusion

    As measured by PCR weekly until week 6, at 3 months, 6 months and 12 months

  2. Immune reconstitution as measured by various laboratory assays of immune cell type and function

    Time frame: During observation period until 12 months post infusion

    ELISpot on peripheral blood is assessed at the time points mentioned above

  3. All cause mortality

    Time frame: At 12 months

    Within the 12 months observation period

  4. Transplant-related outcomes

    Time frame: During observation period until 12 months post infusion

    Incidence/severity of graft-versus-host disease, solid organ rejection episodes, relapse

  5. Incidence/severity of graft-versus-host disease among patients who underwent stem cell transplantation

    Time frame: During observation period until 12 months post infusion

    Based on standardized assessments done weekly until week 6 and at 3, 6 and 12 months

  6. Number and severity of solid organ rejection episodes per patient among those who underwent solid organ transplant

    Time frame: During observation period until 12 months post infusion

    Based on standardized assessments done weekly until week 6 and at 3, 6 and 12 months

  7. Incidence of primary disease relapse among patients who underwent stem cell transplantation

    Time frame: During observation period until 12 months post infusion

    Based on standardized assessments done weekly until week 6 and at 3, 6 and 12 months

  8. Malignancy staging for patients with lymphoma, per internationally-accepted guidelines for the different specific lymphomas

    Time frame: During observation period until 12 months post infusion

    As clinically indicated by the investigators and/or primary physician

Sponsors and collaborators

Lead sponsor

Dr. Jean-Sebastien Delisle, MD, PhD

Other

Registry information

Official study 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

Acronym: EBV-TCL-01

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Oct 20, 2015
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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