drugset / Trial / NCT02115126

Phase II Trial to Evaluate an EBV-derived Dendritic Cell Vaccine in Autologous Stem Cell Transplant

NCT02115126 ↗

Phase 2 Withdrawn David Rizzieri, MD
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a non-blinded, not placebo controlled, randomized, parallel phase 2 pilot study to evaluate the immunological response and the safety of Epstein Barr Virus (EBV)-derived tumor antigen, Latent Membrane Protein-2 (LMP2)-loaded dendritic cell (DC) vaccines alone or co-administered with the TLR9 ligand, DUK-CPG-001, in patients with EBV+ lymphoma in the setting of autologous stem cell transplant with infusion of mature T cells. Patients will be randomized to receive vaccine alone or vaccine co-administered with the TLR9 ligand, DUK-CPG-001. Randomization will be stratified by 2 disease types: Hodgkin lymphoma and non-Hodgkin lymphoma.

Timeline

Start
2016-12
Primary completion
2020-01
Completion
2025-01

Drugs

EvaluationDrugModalityDoseRoute
Subject DUK-CPG-001 Unknown 5 mg Subcutaneous
Comparator LMP2A-loaded conventional DC vaccine Vaccine 3e+07 cells Intravenous