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Clinical trial

Open-Label Individual Patient Study of Epstein-Barr Virus (EBV) Specific T-Cell Lines for the Treatment of a Lymphoproliferative Disease and Hemophagocytic Syndrome Associated With EBV

ID
Name
2024-3579
Description
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 arms
Trial start
2024-01-16
Estimated PCD
2025-04-05
Trial end
2025-04-05
Status
Recruiting
Treatment
EBV-specific T cells
Consolidative cellular immunotherapy consisting of one (or up to 4) infusion of ex vivo expanded T cells
Size
1
Primary endpoint
Safety of a donor-derived EBV-specific T-cell line as assessed clinically by the lack of graft-versus-host host (GVHD).
1 year
Eligibility criteria
Inclusion Criteria: 1. Capacity to provide informed consent 2. Age ≥ 18 3. Negative serum pregnancy test and use of effective contraception method. Exclusion Criteria: 1. Administration within less than 28 days of T-cell depleting antibodies (ATG, OKT3, Campath) 2. Pregnancy 3. Any abnormal condition or laboratory result that is considered by the Principal Investigator capable of altering patient or study outcome. 4. Active uncontrolled GVHD (acute GVHD grade II-IV or progressive extensive chronic GVHD) at time of enrolment or infusion.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single patient', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ESTIMATED'}}
Updated at
2024-04-30

1 organization

1 product

1 indication

Organization
CIUSSS de l'Est de l'Île de Montréal
Product
EBV-specific T cells
Indication
Epstein-Barr Virus Associated Lymphoma