A Study of the Safety and Efficacy of EBV Specific T-cell Lines (EBV-TCL-01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02580539|
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : September 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Epstein-Barr Virus Infections Post-Transplant Lymphoproliferative Disorder Lymphoma||Biological: Group A Biological: Group B||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
Experimental: Autologous or allogenic (stem cell donor) T cells
Subjects receive an autologous anti-EBV T-cell line or a T-cell line derived from the patient's allogeneic (stem cell transplant) donor.
Biological: Group A
Peptide-stimulated T cells 2 x 10^7/m^2
Experimental: Allogeneic "third party" T cells
Subjects receive a T-cell line from a matched or partially matched related donor.
Biological: Group B
Peptide-stimulated T cells per dose-escalation protocol
- 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
- 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
- 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
- All cause mortality [ Time Frame: At 12 months ]Within the 12 months observation period
- 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
- 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
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580539
|Contact: Jean-Sebastien Delisle, MD,PhD||(514) firstname.lastname@example.org|
|Contact: Stephanie Thiant||(514) 252-4681|
|Principal Investigator:||Jean-Sebastine Delisle, MD,PhD||Maisonneuve-Rosemont Hospital|