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

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

Inclusion criteria

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

Exclusion criteria

• 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.