Tests donor immune cells against EBV-driven lymphomas and related diseases
Tests donor-derived immune cells in patients with EBV-driven lymphoma or PTLD.
Plain-language title generated from the registry record
Registry title: EBV-Tscm Cytotoxic T Cells (CTLs) for EBV- Driven Lymphomas/ Diseases
Key facts
- Where
- Basel, Bern, Geneva, Lausanne, and Zurich, SwitzerlandSee the 8 sites
- Phase
- Phase 1/2
Where in Switzerland
- Universitäts-Kinderspital beider Basel (UKBB)Basel, SwitzerlandNo longer taking part
- University Hospital Basel, Klinik für Infektiologie und SpitalhygieneBasel, SwitzerlandNo longer taking part
- Universitätsspital Bern, Klinik für InfektiologieBern, SwitzerlandNo longer taking part
- Hôpitaux Universitaires de Genève, Hôpital des EnfantsGeneva, SwitzerlandNo longer taking part
- Hôpitaux Universitaires de Genève, Service d'HématologieGeneva, SwitzerlandNo longer taking part
- Centre hospitalier universitaire vaudois, Service et Laboratoire central d'hématologieLausanne, SwitzerlandNo longer taking part
- Kinderspital ZürichZurich, SwitzerlandNo longer taking part
- University Hospital Zurich, HämatologieZurich, SwitzerlandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Basel, Switzerland
- Trial code
- NCT05688241
- Record updated
- 3 March 2025
- Original description
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.Read full original descriptionShow less
Epstein-Barr Virus (EBV) -Specific T Memory Stem Cell (Tscm) Therapy to Treat 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 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.