drugset / Trial / NCT03131934

Immunotherapy With Tacrolimus Resistant EBV CTL for Lymphoproliferative Disease After Solid Organ Transplant

NCT03131934 ↗

NaSingle-groupOpen-labelTreatment

Summary

This is an open label, non-randomised, multicentre Phase I to determine the safety of tacrolimus-resistant autologous EBV-specific cytotoxic T-cells (EBV CTL) and compare their expansion/persistence with control EBV CTL in solid organ transplant patients with post-transplant lymphoproliferative disease (PTLD). Each patient will receive an infusion of two ATIMPs - autologous EBV CTL retrovirally transduced with (a) a calcineurin mutant (CNA12) that confers resistance to tacrolimus and (b) a control calcineurin mutant (CNA8).

Timeline

Start
2019-05-31
Primary completion
2020-06-30
Completion
2025-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject tabelecleucel Cell therapy 1e+07 cells Intravenous