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T-cell Therapy

EBV Specific T-cell Therapy for Lymphoma (EBV-TCL-01 Trial)

Phase 1 & 2
Recruiting
Led By Jean-Sebastine Delisle, MD,PhD
Research Sponsored by Dr. Jean-Sebastien Delisle, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed treatment-refractory EBV reactivation or EBV-related lymphoma
Capacity to provide informed consent
Must not have
Medical condition requiring a corticosteroid dose greater than Prednisone 0.5mg/kg/day (or equivalent) at the time of the infusion
Active uncontrolled GVHD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if T-cells from donors can help treat EBV-related lymphoma in patients who don't respond to standard therapies. 6 will get T-cells from themselves or donors, 6 from related donors.

Who is the study for?
This trial is for adults over 18 with stubborn EBV infections or related lymphoma that haven't improved with standard treatments. Participants should be fairly active (ECOG ≤2), not have had a solid organ transplant recently, and can't be pregnant or severely ill from other causes. If they've had a stem cell transplant, their donor must be a close relative who's compatible and willing to donate cells.
What is being tested?
The study tests the safety and effectiveness of EBV-specific T-cell lines in two groups: one receiving T-cells made from their own cells or those of their stem cell donor, and another group getting T-cells from a matched family member. Each group will include six patients.
What are the potential side effects?
Potential side effects may include immune reactions due to infused T-cells attacking the body's own tissues, infusion-related symptoms like fever or chills, fatigue, infection risk increase due to immune system modification, and possible GVHD in stem cell recipients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is resistant to treatment for EBV reactivation or EBV-related lymphoma.
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I understand and can agree to the study's procedures and risks.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need a high dose of steroids daily for my medical condition.
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I have active and uncontrolled graft-versus-host disease.
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I have not had T-cell depleting therapy or a stem cell transplant in the last 28 days.
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I have been told I have less than 3 months to live due to a condition not related to my EBV disease.
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I received an organ transplant within the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety: Incidence and description of CTCAE v.4.03 adverse events related to the experimental treatment
Secondary study objectives
All cause mortality
Changes in EBV titers (viral load) for each patient
Immune reconstitution as measured by various laboratory assays of immune cell type and function
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Autologous or allogenic (stem cell donor) T cellsExperimental Treatment1 Intervention
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 II: Allogeneic "third party" T cellsExperimental Treatment1 Intervention
Subjects receive a T-cell line from a matched or partially matched related donor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Group B
2015
N/A
~2200
Group A
2015
N/A
~2340

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Dr. Jean-Sebastien Delisle, MD, PhDLead Sponsor
Jean-Sebastine Delisle, MD,PhDPrincipal InvestigatorMaisonneuve-Rosemont Hospital
Jean-Sebastien Delisle, MD,PhDPrincipal InvestigatorMaisonneuve-Rosemont Hospital

Media Library

Group A (T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02580539 — Phase 1 & 2
Epstein-Barr Virus Infection Research Study Groups: Autologous or allogenic (stem cell donor) T cells, Allogeneic "third party" T cells
Epstein-Barr Virus Infection Clinical Trial 2023: Group A Highlights & Side Effects. Trial Name: NCT02580539 — Phase 1 & 2
Group A (T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02580539 — Phase 1 & 2
~1 spots leftby Nov 2025
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