Development of technology platforms for in-depth in vitro safety profile evaluation of CAR T cells and T cells transduced with TCRs (T Cell Receptors)

Optimization of the platform for genetic modification of T cells, focusing on key elements to maximize the effectiveness and safety of the process

Enhancement of a service platform for GMP-grade (Good Manufacturing Practice) production of genetically engineered immune cells in one of the two GMP-approved academic facilities

Support for the development and authorization of additional GMP-compliant facilities (Good Manufacturing Practice) in participating institutions IRCCS AOU BO, CNR, and AOP

Validation and sharing of standardized protocols to monitor the persistence and expansion of CAR T cells, as well as their detection in different biological fluids

Validation of the use of non-invasive approaches such as liquid biopsy for monitoring residual circulating tumor cells after treatment and for validating predictive biomarkers of response

Development of an integrated platform for managing Clinical/Regulatory aspects, including the submission of the Investigational Medicinal Product Dossier (IMPD) and interaction with Regulatory Agencies