Work Packages

In the first year the project starts with creating the basis for manufacturing of the multivirus-specific T-cell product by harmonizing and validating the GMP-production and obtaining the issuance of manufacturing permissions (WP 1: Harmonization and validation of GMP-production). In parallel preconditions for the clinical study will be generated (WP 2: Set-up of the clinical trial), meaning finalization of the clinical trial documents, coordinating submission of the trial to the national competent authorities and institutional ethical review boards and setting-up the infrastructure. Within Work package 3 (Conduct of the clinical trial) feasibility assessment, clinical trial site initiation, source data verification, safety monitoring, data cleaning and data base closure throughout the trial will be performed. Interim analysis of the primary endpoint and final statistical analysis will be performed by the Institute for Medical Information Sciences, Biometry and Epidemiology (IBE) of the LMU. During the trial in month 11 to 50, clinical sample analysis and immune monitoring will be carried out in WP 4 (Immune monitoring and accompanying research). The publication of results as well as preparation of documents for drug approval and market authorization will be carried out in WP 5 (Communication, dissemination and exploitation of results). As project coordinator LMU will ensure the proper functioning of the project in order to achieve the objectives in WP 6 (Project management and communication) by supporting the participants to complete the milestones and deliverables, ensuring contractual duties to be carried out and setting up the communication infrastructure.