EBV-Tscm Cytotoxic T Cells (CTLs) for EBV- Driven Lymphomas/ Diseases (ESPECT)
EBV Lymphoma, Post-transplant Lymphoproliferative Disease (PTLD)
About this trial
This is an interventional treatment trial for EBV Lymphoma focused on measuring EBV-driven Lymphomas, EBV disease, Epstein-Barr Virus (EBV), Memory Stem Cell Therapy, Epstein-Barr Virus-specific T Memory Stem Cell Therapy (EBV-Tscm), cytotoxic T-cell line (CTL), T memory stem cells (Tscm), T-cell receptor (TCR), post-transplant lymphoproliferative disease (PTLD), Wnt-β-catenin inhibition, hematopoietic cell transplantation (HCT), Hematopoietic stem cell transplantation (HSCT)
Eligibility Criteria
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 HCT Group B: EBV-driven PTLD that develop after a HCT or SOT For both groups: All age groups Negative pregnancy test in female patients of childbearing potential. Signed written informed consent of patient or/and parents Patients' exclusion criteria: Patients receiving anti-thymocyte globulin or Campath within 28 days of infusion Patients with active, acute GvHD grades III-IV Previous 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 pool Suitability for blood or HCT donation meeting requirements of local institutional guidelines An informed consent for EBV Tscm CTL manufacturing Age > 18 years Donors' exclusion criteria: Detectable IFN-y-secreting T-cells <100 spot-forming cell (SFC)/10e6 PBMC measured by Elispot to EBV select Unwilling and/or unable to donate, according to the donor center
Sites / Locations
- University Hospital Basel, Klinik für Infektiologie und Spitalhygiene
- Universitäts-Kinderspital beider Basel (UKBB)
- Universitätsspital Bern, Klinik für Infektiologie
- Hôpitaux Universitaires de Genève, Hôpital des Enfants
- Hôpitaux Universitaires de Genève, Service d'Hématologie
- Centre hospitalier universitaire vaudois, Service et Laboratoire central d'hématologie
- Kinderspital Zürich
- University Hospital Zurich, Hämatologie
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A: patients who undergo allogeneic HCT
Group B: patients after HCT or SOT
Patients with EBV driven lymphomas (e.g., natural killer (NK)/T-cell lymphoma), with EBV complications (e.g. haemophagocytic lymphohistiocytosis (HLH), CAEBV) or patients with primary immunodeficiency disorders with high risk for EBV complications (e.g. SCID) with planned allogeneic HCT.
EBV-driven PTLD that develop after a HCT or solid organ transplantation (SOT) and show decreased response to rituximab.