EBV-Tscm Cytotoxic T Cells (CTLs) for EBV- Driven Lymphomas/ Diseases

In this multi-center open-label, non-randomized phase I/II intervention study three consecutive doses of donor-derived EBV Tscm-CTLs will be administered to 10 patients with treatment-refractory EBV lymphoma, diseases or PTLDs. EBV Tscm-CTLs will derive from hematopoietic cell transplant (HCT) or third-party donors.

Patients' inclusion criteria:Group A: Patients with EBV driven lymphomas (e.g., NK/T-cell lymphoma), with EBV complications (e.g. HLH, CAEBV) or patients with primary immunodeficiency disorders with high risk for EBV complications (e.g. SCID) with planned allogeneic HCTGroup B: EBV-driven PTLD that develop after a HCT or SOTFor both groups:All age groupsNegative pregnancy test in female patients of childbearing potential.Signed written informed consent of patient or/and parentsPatients' exclusion criteria:Patients receiving anti-thymocyte globulin or Campath within 28 days of infusionPatients with active, acute GvHD grades III-IVPrevious severe reaction to dimethylsulfoxide (DMSO)Donors' inclusion criteria:EBV positive serology (VCA and Epstein-Barr nuclear antigen (EBNA) immunoglobulin G (IgG) positive)Detectable interferon (IFN)-y-secreting T cells (>100 SFC/10e6 PBMC) measured by Elispot to the EBV consensus peptide poolSuitability for blood or HCT donation meeting requirements of local institutional guidelinesAn informed consent for EBV Tscm CTL manufacturingAge > 18 yearsDonors' exclusion criteria:Detectable IFN-y-secreting T-cells <100 spot-forming cell (SFC)/10e6 PBMC measured by Elispot to EBV selectUnwilling and/or unable to donate, according to the donor center