NCT02580539

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

9.5 years

First QC Date

October 15, 2015

Last Update Submit

May 11, 2025

Conditions

Epstein-Barr Virus InfectionsPost-Transplant Lymphoproliferative DisorderLymphoma

Keywords

Allogeneic TransplantationT cellEpstein-Barr Virus

Outcome Measures

Primary Outcomes (1)

  • Safety: Incidence and description of CTCAE v.4.03 adverse events related to the experimental treatment

    Complications: infusional toxicity, immune-related and other

    During observation period (up to 42 days post infusion)

Secondary Outcomes (8)

  • Changes in EBV titers (viral load) for each patient

    Until 12 months post infusion

  • Immune reconstitution as measured by various laboratory assays of immune cell type and function

    During observation period until 12 months post infusion

  • All cause mortality

    At 12 months

  • Transplant-related outcomes

    During observation period until 12 months post infusion

  • Incidence/severity of graft-versus-host disease among patients who underwent stem cell transplantation

    During observation period until 12 months post infusion

  • +3 more secondary outcomes

Study Arms (2)

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.

Biological: Group A

Allogeneic "third party" T cells

EXPERIMENTAL

Subjects receive a T-cell line from a matched or partially matched related donor.

Biological: Group B

Interventions

Group ABIOLOGICAL

Peptide-stimulated T cells 2 x 10\^7/m\^2

Autologous or allogenic (stem cell donor) T cells
Group BBIOLOGICAL

Peptide-stimulated T cells per dose-escalation protocol

Allogeneic "third party" T cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Capacity to provide informed consent
  • Age ≥ 18 years old
  • Confirmed treatment-refractory EBV reactivation or EBV-related lymphoma
  • ECOG of 2 or less

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Related Links

MeSH Terms

Conditions

Epstein-Barr Virus InfectionsLymphoma

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jean-Sebastien Delisle, MD,PhD

    Maisonneuve-Rosemont Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinician-Scientist, Hematopoietic Cell Transplantation Program

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 20, 2015

Study Start

November 1, 2015

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)