Specific immunotherapy against MUC-1 antigen - Study TG4010.04 : "Phase II study with TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer", Study TG4010.05 : "Phase II study with TG 4010 in patients with non small cell lung cancer"

Study title: 
Specific immunotherapy against MUC-1 antigen - Study TG4010.04 : "Phase II study with TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer", Study TG4010.05 : "Phase II study with TG 4010 in patients with non small cell lung cancer"
EU record number: 
B/BE/01/B7
Pharmaceutical study code: 
TG4010.04, TG4010.05
Company / Sponsor: 
Transgene S.A.
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Metastatic Breast Cancer, Non-Small Cell Lung cancer
Therapeutic approach: 
Immunotherapy
Genetic modification: 
sequences coding for the human MUC-1 antigen and IL-2
Method of transfer of nucleic acid of interest: 
Attenuated Vaccinia Virus (Ankara Strain)
Administered biological material: 
Recombinant Attenuated Vaccinia Virus
Route of administration: 
subcutaneous
Locations in Belgium: 
Erasme Hospital, Brussels
Nr of subjects: 
not specified (up to 166 patients in Europe)
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

Information related to the decision procedure