A Study of the Safety and Efficacy of EBV Specific T-cell Lines
NCT ID: NCT02580539
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2015-11-30
2025-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Group A
Peptide-stimulated T cells 2 x 10\^7/m\^2
Allogeneic "third party" T cells
Subjects receive a T-cell line from a matched or partially matched related donor.
Group B
Peptide-stimulated T cells per dose-escalation protocol
Interventions
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Group A
Peptide-stimulated T cells 2 x 10\^7/m\^2
Group B
Peptide-stimulated T cells per dose-escalation protocol
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old
* Confirmed treatment-refractory EBV reactivation or EBV-related lymphoma
* ECOG of 2 or less
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Dr. Jean-Sebastien Delisle, MD, PhD
OTHER
Responsible Party
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Dr. Jean-Sebastien Delisle, MD, PhD
Clinician-Scientist, Hematopoietic Cell Transplantation Program
Principal Investigators
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Jean-Sebastien Delisle, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Maisonneuve-Rosemont Hospital
Locations
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Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Countries
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Related Links
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Center for Excellence in Cell Therapy
Other Identifiers
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CER15020
Identifier Type: -
Identifier Source: org_study_id
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