Clinical trial NCT06391814: Donor-Derived EBV-Specific T Cells for Life Threatening EBV-lymphoma (OLIP-EBV-TCL-01-HMR01)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: EBV Associated Lymphoma
Keywords: Adoptive immunotherapy
EBV
Systemic EBV-positive T-cell lymphoma of childhood
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single patient
Primary purpose: TREATMENT

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.

Detailed 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

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.

Primary outcomes:
measure: Safety of a donor-derived EBV-specific T-cell line as assessed clinically by the lack of graft-versus-host host (GVHD).
timeFrame: 1 year
Secondary outcomes:
measure: Clinical response
timeFrame: 1 year
measure: Immune reconstitution to EBV
timeFrame: 1 year
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Ciusss-Emtl
state: Quebec
Study officials:
References: