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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland

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

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