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NCT05688241Not yet recruiting

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

Summary

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.

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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Not yet recruiting
Phase
Phase 1 · Phase 2
Study type
Interventional
Countries
Switzerland
Sponsor
University Hospital, Basel, Switzerland(Other)
Protocol no.
2022-01210; am22Khanna
Conditions
EBV Lymphoma, Post-transplant Lymphoproliferative Disease (PTLD)
Interventions
Drug

Treatments studied

  • Donor-derived ex-vivo expanded EBV Tscm CTL

Locations · 8

  • Basel, SwitzerlandUniversity Hospital Basel, Klinik für Infektiologie und SpitalhygieneNot yet recruiting at this site
  • Basel, SwitzerlandUniversitäts-Kinderspital beider Basel (UKBB)Not yet recruiting at this site
  • Bern, SwitzerlandUniversitätsspital Bern, Klinik für InfektiologieNot yet recruiting at this site
  • Geneva, SwitzerlandHôpitaux Universitaires de Genève, Hôpital des EnfantsNot yet recruiting at this site
  • Geneva, SwitzerlandHôpitaux Universitaires de Genève, Service d'HématologieNot yet recruiting at this site
  • Lausanne, SwitzerlandCentre hospitalier universitaire vaudois, Service et Laboratoire central d'hématologieNot yet recruiting at this site
  • Zurich, SwitzerlandKinderspital ZürichNot yet recruiting at this site
  • Zurich, SwitzerlandUniversity Hospital Zurich, HämatologieNot yet recruiting at this site

In total, worldwide, all 8 sites listed in the registry are planned; recruitment has not opened yet.

Site status per the ClinicalTrials.gov registry (last update posted: March 3, 2025).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.