Epstein-Barr Virus InfectionsPhase 1/2EBV-TCL-01NCT02580539
A Study of the Safety and Efficacy of EBV Specific T-cell Lines
A Phase 1/2 study testing Group A and Group B in people with Epstein-Barr Virus Infections and Post-Transplant Lymphoproliferative Disorder, run by Dr. Jean-Sebastien Delisle, MD, PhD at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epstein-Barr Virus Infections, Post-Transplant Lymphoproliferative Disorder, Lymphoma
- What is being tested?
- Group A and Group B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to May 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Capacity to provide informed consent
- Age ≥ 18 years old
- Confirmed treatment-refractory EBV reactivation or EBV-related lymphoma
- ECOG of 2 or less
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Being tested
- Group A, Group B
- Keywords
- Allogeneic Transplantation, T cell, Epstein-Barr Virus
- Medical subject headings
- Epstein-Barr Virus Infections, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ABiological
Peptide-stimulated T cells 2 x 10^7/m^2
Group BBiological
Peptide-stimulated T cells per dose-escalation protocol
| Study group | Role | What they receive |
|---|---|---|
| Autologous or allogenic (stem cell donor) T cells | Experimental | Subjects receive an autologous anti-EBV T-cell line or a T-cell line derived from the patient's allogeneic (stem cell transplant) donor. Receives: Biological: Group A |
| Allogeneic "third party" T cells | Experimental | Subjects receive a T-cell line from a matched or partially matched related donor. Receives: Biological: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence and description of CTCAE v.4.03 adverse events related to the experimental treatment
Complications: infusional toxicity, immune-related and other
Measured: During observation period (up to 42 days post infusion)
Secondary outcomes (8)
Changes in EBV titers (viral load) for each patient
As measured by PCR weekly until week 6, at 3 months, 6 months and 12 months
Measured: Until 12 months post infusion
Immune reconstitution as measured by various laboratory assays of immune cell type and function
ELISpot on peripheral blood is assessed at the time points mentioned above
Measured: During observation period until 12 months post infusion
All cause mortality
Within the 12 months observation period
Measured: At 12 months
Transplant-related outcomes
Incidence/severity of graft-versus-host disease, solid organ rejection episodes, relapse
Measured: During observation period until 12 months post infusion
Incidence/severity of graft-versus-host disease among patients who underwent stem cell transplantation
Based on standardized assessments done weekly until week 6 and at 3, 6 and 12 months
Measured: During observation period until 12 months post infusion
Number and severity of solid organ rejection episodes per patient among those who underwent solid organ transplant
Based on standardized assessments done weekly until week 6 and at 3, 6 and 12 months
Measured: During observation period until 12 months post infusion
Incidence of primary disease relapse among patients who underwent stem cell transplantation
Based on standardized assessments done weekly until week 6 and at 3, 6 and 12 months
Measured: During observation period until 12 months post infusion
Malignancy staging for patients with lymphoma, per internationally-accepted guidelines for the different specific lymphomas
As clinically indicated by the investigators and/or primary physician
Measured: During observation period until 12 months post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2025
- Study completionMay 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epstein-Barr Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Jean-Sebastien Delisle, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Jean-Sebastien Delisle, MD, PhD, Maisonneuve-Rosemont Hospital
- Investigators
- Jean-Sebastien Delisle, MD,PhD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580539
- Sponsor's protocol ID
- CER15020
- Acronym
- EBV-TCL-01
- Status last verified
- May 2025
- First submitted
- 15 Oct 2015
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02580539
- Acronym / sponsor ID
- EBV-TCL-01 / CER15020
- Keywords
- Allogeneic Transplantation, T cell, Epstein-Barr Virus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Dr. Jean-Sebastien Delisle, MD, PhDUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2025 (actual)
- Study completion
- May 2025 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous or allogenic (stem cell donor) T cells | Experimental | Biological: Group ASubjects receive an autologous anti-EBV T-cell line or a T-cell line derived from the patient's allogeneic (stem cell transplant) donor. |
| Allogeneic "third party" T cells | Experimental | Biological: Group BSubjects receive a T-cell line from a matched or partially matched related donor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Capacity to provide informed consent
- Age ≥ 18 years old
- Confirmed treatment-refractory EBV reactivation or EBV-related lymphoma
- ECOG of 2 or less
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group APeptide-stimulated T cells 2 x 10^7/m^2 | Biological | Autologous or allogenic (stem cell donor) T cells |
| Group BPeptide-stimulated T cells per dose-escalation protocol | Biological | Allogeneic "third party" T cells |
Primary outcome
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
8 secondary outcomes
Changes in EBV titers (viral load) for each patient
Time frame: Until 12 months post infusion
Immune reconstitution as measured by various laboratory assays of immune cell type and function
Time frame: During observation period until 12 months post infusion
All cause mortality
Time frame: At 12 months
Transplant-related outcomes
Time frame: During observation period until 12 months post infusion
Incidence/severity of graft-versus-host disease among patients who underwent stem cell transplantation
Time frame: During observation period until 12 months post infusion
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
Incidence of primary disease relapse among patients who underwent stem cell transplantation
Time frame: During observation period until 12 months post infusion
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Center for Excellence in Cell TherapyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Sebastien Delisle, MD,PhD principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Group A and Group B in people with Epstein-Barr Virus Infections and Post-Transplant Lymphoproliferative Disorder, run by Dr. Jean-Sebastien Delisle, MD, PhD at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.