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

Ciusss de L'Est de l'Île de Montréal

Status: Enrolling

Conditions: EBV Associated Lymphoma

Treatments: Biological: EBV-specific T cells

Study type: Interventional

Funder types: Other

Identifiers

NCT06391814

2024-3579

Details and patient eligibility

About

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.

Full 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

Enrollment: 1 estimated patient

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)