Donor-Derived EBV-Specific T Cells for Life Threatening EBV-lymphoma (OLIP-EBV-TCL-01-HMR01)

EBV Associated Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06391814
• Other study ID #: 2024-3579
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: April 5, 2025

Study information

• Verified date: April 2024
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: Jean-Sébastien Delisle, MD, PhD
• Phone: 514-252-3400
• Email: js.delisle[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Following a presumed primary EBV infection, a 19 year old female patient rapidly suffered systemic inflammatory response, hemophagocytosis, multi-organ failure and evidence of EBV+ T-cell lymphoma. The patient was aggressively treated and responded to SMILE-based chemotherapy. Once complete response was ascertained by PET imaging, the patient underwent myeloablative HLA-matched unrelated allogeneic stem cell transplantation (cyclophosphamide 60mg/Kg, total body irradiation - 12Gy with anti-thymocyte globulin). The stem cell donor had a positive serology for EBV (IgG). The patient's EBV titer was weakly positive at the time of transplantation. A decision was made to offer consolidative treatment consisting of donor-derived ex vivo expanded EBV-reactive T cells following transplantation. A EBV-specific T-cell line was manufactured from a portion of the cryopreserved G-CSF mobilized peripheral graft after appropriate authorizations were obtained. The patient suffered a severe episode of intestinal graft-versus-host disease early following transplantation but received a first dose of EBV-reactive T cells (20x10e6 T cells/meter square of body surface area 5 months post-transplantation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: April 5, 2025
• Est. primary completion date: April 5, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• EBV Associated Lymphoma
• Lymphoma

Intervention

Biological:
• EBV-specific T cells
Consolidative cellular immunotherapy consisting of one (or up to 4) infusion of ex vivo expanded T cells

Locations

Country	Name	City	State
Canada	Ciusss-Emtl	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical response	Disease recurrence as assessed by imaging (PET scanning)	1 year
Secondary	Immune reconstitution to EBV	Measurement of viral titers (nucleic acid testing) and peripheral blood ELISpot measurements	1 year