Dose-escalation Study to Assess the Safety and Tolerability of Sub-cutaneous Injections of GeniusVac-Mel4 in Patients With Melanoma
GeniusVac-Mel4 corresponds to an irradiated allogeneic plasmacytoid dendritic cell line
loaded with 4 melanoma peptides. This cell line is HLA-A*0201, a phenotype found in 40% of
the European population. This approach exploits the pDC line high capacity of boosting
anti-tumor cytotoxic response against melanoma antigens in HLA-A*201 melanoma patients. In
the preclinical studies, its efficacy was shown in melanoma in vivo in humanized mice and ex
vivo from the PBMC (peripheral blood mononuclear cells) of patients.
It is planned to include patients in three dose-escalating groups (4, 20, 60 millions of
GeniusVac-Mel4 cells). 3 patients will be recruited in each dose group of the trial.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tolerability and safety of a multiple sub-cutaneous injections of GeniusVac-Mel4.
Safety and tolerance will be clone monitored by performing clinical laboratory tests, assessments of vital signs, full clinical examination, occurrence of adverse events.
Joel Plumas, PhD
Etablissement Français du Sang
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
DCIC 11 19