Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
NCT Number: NCT02580539
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Montreal, Quebec, H1T 2M4, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Peptide-stimulated T cells 2 x 10^7/m^2
Peptide-stimulated T cells per dose-escalation protocol
Time frame: During observation period (up to 42 days post infusion)
Complications: infusional toxicity, immune-related and other
Time frame: Until 12 months post infusion
As measured by PCR weekly until week 6, at 3 months, 6 months and 12 months
Time frame: During observation period until 12 months post infusion
ELISpot on peripheral blood is assessed at the time points mentioned above
Time frame: At 12 months
Within the 12 months observation period
Time frame: During observation period until 12 months post infusion
Incidence/severity of graft-versus-host disease, solid organ rejection episodes, relapse
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
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
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
Time frame: During observation period until 12 months post infusion
As clinically indicated by the investigators and/or primary physician
Dr. Jean-Sebastien Delisle, MD, PhD
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT03258567
DNA Virus Infections, Disorders, Lymphoproliferative
Bethesda, Maryland, United States
View Trial DetailsNCT03546101
DNA Virus Infections, Epstein-Barr Viraemia
Aarhus, Central Region of Denmark, Denmark
View Trial DetailsNCT07256431
DNA Virus Infections, Epstein-Barr Virus Infections
Nîmes, France
View Trial DetailsNCT04693637
Adenoviridae Infections, Adenovirus Infection
Birmingham, Alabama, United States
View Trial Details