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

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Jan 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with certain types of lymphomas related to the Epstein-Barr virus (EBV), particularly for those who haven't responded to other treatments. The trial will involve giving three doses of a special type of immune cells, called EBV Tscm Cytotoxic T Cells (CTLs), which are derived from either bone marrow transplants or other healthy donors. The goal is to see if these cells can help fight the EBV-related diseases, including lymphomas and post-transplant lymphoproliferative disease (PTLD).

To be eligible for the trial, patients must have specific types of EBV-related conditions, such as certain lymphomas or complications from prior transplants. Both adults and children can participate, provided they have a signed consent form. However, there are some exclusions, such as recent treatments that could interfere with the trial or certain severe health conditions. This trial is currently not recruiting participants, but it aims to bring hope to those struggling with these difficult diseases by testing a potentially effective new therapy.

Gender

ALL

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