The ultimate goal, starting from studies at the gene, protein, cell and pre-clinical setting, is to translate the acquired knowledge into therapeutic endpoints. Within DC-THERA a critical mass of scientists and clinicians has been created who will be able to validate a number of different DC-based approaches for treatment of several cancers as well as HIV (WP9). The reason cancer is chosen as an initial focus for clinical trials of DC-based immunotherapy is because proof of principle has already been obtained in this setting, treatment modalities are the most advanced in this area, and these trials are feasible for patients with advanced cancers who have failed all other treatment options. Initially the participants will conduct a variety of phase I/II clinical trials, but conceivably may initiate phase III trials towards the end of the contract. Results however cannot be evaluated on the basis of clinical responses alone. Hence a series of sophisticated immuno-monitoring techniques will be applied and developed to assess the patient’s immune response to these therapies in relation to clinical outcome (WP10; see also information from Cluster 1). If immunological (or e.g. transcriptional) correlates can be identified and confirmed, they will enormously speed the progress of translational research in the area. Finally, as a major contribution to future European policy in the area, DC-THERA will take its accumulated knowledge from these clinical studies and consider it in the light of current standards and legislation in the field, with a view to reshaping policy relating to DC-based therapies well after the end of the project (WP11).