drugset / Trial / NCT02115126
Phase II Trial to Evaluate an EBV-derived Dendritic Cell Vaccine in Autologous Stem Cell Transplant
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DUK-CPG-001 | Unknown | 5 mg | Subcutaneous |
| Comparator | LMP2A-loaded conventional DC vaccine | Vaccine | 3e+07 cells | Intravenous |