drugset / Trial / NCT01863108
Safety Study of a Dendritic Cell-based Cancer Vaccine in Melanoma
Phase 1
Completed
9 enrolled
University Hospital, Grenoble
Etablissement Français du Sang · collabInstitut National de la Santé Et de la Recherche Médicale, France · collabUniversité Joseph Fourier · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the safety and tolerability of multiple sub-cutaneous injections of GeniusVac-Mel4, a dendritic cell-based cancer vaccine, in patients with melanoma. The secondary objectives are to determine immune response and clinical efficacy of such injections in patients with melanoma.
Timeline
- Start
- 2013-06
- Primary completion
- 2017-03-23
- Completion
- 2017-03-23
Publications
- Background Aspord C, Leccia MT, Salameire D, Laurin D, Chaperot L, Charles J, Plumas J. HLA-A(*)0201(+) plasmacytoid dendritic cells provide a cell-based immunotherapy for melanoma patients. J Invest Dermatol. 2012 Oct;132(10):2395-2406. doi: 10.1038/jid.2012.152. Epub 2012 Jun 14.
- Background Aspord C, Charles J, Leccia MT, Laurin D, Richard MJ, Chaperot L, Plumas J. A novel cancer vaccine strategy based on HLA-A*0201 matched allogeneic plasmacytoid dendritic cells. PLoS One. 2010 May 4;5(5):e10458. doi: 10.1371/journal.pone.0010458.
- Results Charles J, Chaperot L, Hannani D, Bruder Costa J, Templier I, Trabelsi S, Gil H, Moisan A, Persoons V, Hegelhofer H, Schir E, Quesada JL, Mendoza C, Aspord C, Manches O, Coulie PG, Khammari A, Dreno B, Leccia MT, Plumas J. An innovative plasmacytoid dendritic cell line-based cancer vaccine primes and expands antitumor T-cells in melanoma patients in a first-in-human trial. Oncoimmunology. 2020 Apr 12;9(1):1738812. doi: 10.1080/2162402X.2020.1738812. eCollection 2020.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GeniusVac-Mel4 | Vaccine | 4 cells | Subcutaneous |
| Subject | GeniusVac-Mel4 | Vaccine | 20 cells | Subcutaneous |
| Subject | GeniusVac-Mel4 | Vaccine | 60 cells | Subcutaneous |