NCT05688241Not yet recruitingPhase 1/2
EBV-Tscm Cytotoxic T Cells (CTLs) for EBV- Driven Lymphomas/ Diseases
Epstein-Barr Virus (EBV) -Specific T Memory Stem Cell (Tscm) Therapy to Treat EBV- Driven Lymphomas/ Diseases
Source: ClinicalTrials.gov · Last updated 3 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 21 Dec 2022
- Start date
- Nov 2026
- Primary completion date
- Dec 2031
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Childhood cancers
- NCT number
- NCT05688241
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 10
- From Nov 2026 to the primary completion date, Dec 2031
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitäts-Kinderspital beider Basel (UKBB) Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| University Hospital Basel, Klinik für Infektiologie und Spitalhygiene Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Universitätsspital Bern, Klinik für Infektiologie Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Hôpitaux Universitaires de Genève, Hôpital des Enfants Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Hôpitaux Universitaires de Genève, Service d'Hématologie Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Centre hospitalier universitaire vaudois, Service et Laboratoire central d'hématologie Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Kinderspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| University Hospital Zurich, Hämatologie Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.