A Study of the Safety and Efficacy of EBV Specific T-cell Lines (EBV-TCL-01)

Dr. Jean-Sebastien Delisle, MD, PhD

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lymphoma; Epstein-Barr Virus Infections; Post-Transplant Lymphoproliferative Disorder

Treatments: Biological: Group A; Biological: Group B

Study type: Interventional

Funder types: Other

Identifiers

NCT02580539

CER15020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Autologous or allogenic (stem cell donor) T cells

Experimental group

Description:

Subjects receive an autologous anti-EBV T-cell line or a T-cell line derived from the patient's allogeneic (stem cell transplant) donor.

Treatment:

Biological: Group A

Allogeneic "third party" T cells

Experimental group

Description:

Subjects receive a T-cell line from a matched or partially matched related donor.

Treatment:

Biological: Group B