NCT06391814

Brief Summary

Single-patient trial aiming to provide immunological consolidation following allogeneic stem cell transplantation to a young adult patient suffering from a systemic EBV-positive lymphoma of childhood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2025

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

April 22, 2024

Last Update Submit

March 19, 2026

Conditions

EBV Associated Lymphoma

Keywords

Adoptive immunotherapyEBVSystemic EBV-positive T-cell lymphoma of childhood

Outcome Measures

Primary Outcomes (1)

  • Safety of a donor-derived EBV-specific T-cell line as assessed clinically by the lack of graft-versus-host host (GVHD).

    Evaluate the safety in terms of occurrence of graft-versus-host disease of a donor-derived allogeneic EBV-specific T-cell line generation and infusion in a patient suffering from a life-threatening EBV-related disease who received an allogeneic stem cell transplantation. Acute GVHD symptoms will be scored using MAGIC criteria using scores from 0 to IV, IV being the most severe involvement) on skin, liver and gastro-intestinal tract. Chronic GVHD symptoms will be score using the NIH consensus scale (0 to 3, 3 being the most severe) on the following organs skin, mouth, eyes, GI tract, liver, lungs, joints and fascia, and genital tract.

    1 year

Secondary Outcomes (2)

  • Clinical response

    1 year

  • Immune reconstitution to EBV

    1 year

Study Arms (1)

Single patient

EXPERIMENTAL
Biological: EBV-specific T cells

Interventions

EBV-specific T cellsBIOLOGICAL

Consolidative cellular immunotherapy consisting of one (or up to 4) infusion of ex vivo expanded T cells

Single patient

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Capacity to provide informed consent
  • Age ≥ 18
  • Negative serum pregnancy test and use of effective contraception method.

You may not qualify if:

  • Administration within less than 28 days of T-cell depleting antibodies (ATG, OKT3, Campath)
  • Pregnancy
  • Any abnormal condition or laboratory result that is considered by the Principal Investigator capable of altering patient or study outcome.
  • Active uncontrolled GVHD (acute GVHD grade II-IV or progressive extensive chronic GVHD) at time of enrolment or infusion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ciusss-Emtl

Montreal, Quebec, H1T 2M4, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single patient
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2024

First Posted

April 30, 2024

Study Start

January 16, 2024

Primary Completion

April 5, 2025

Study Completion

April 5, 2025

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)