PROJECT
About carxall
PROJECT OBJECTIVES
To complete the pre-Clinical Characterization and validation of carxall product
GMP-compliant scale-up manufacturing process of carxall-directed CORD-GDT cells
To develop a business model and a Regulatory pathway to bring these carxall-directed CORD-GDT cells to patients
Work packages
To optimize the in vitro expansion of de novo generated naïve CORD-GDT cells.
Efficient transduction of CORD-GDT cells with viral vectors expressing single and dual CAR.
To assess the potential of the expanded CORD-GDT cells to recognize and eliminate T-ALL cells.
To analyse their cytotoxic potential armed with both single and dual CAR.
To assess the cytotoxicity, persistence, and exhaustion of the a) CORD-GDT cells in vivo, and b) of the single and dual CAR CORD-GDT cells in vivo.
To confirm the absence of pro-tumorigenic effects of the de novo generated CORD-GDT cells in vivo
To design and optimize a scalable GMP-compatible bioprocess based on relevant EMA guidelines to manufacture clinically relevant doses for comprehensive characterization of cells’ critical quality attributes (CQA).
To provide regulatory support and advice during the execution of the whole project:
- Regulatory pathway
- Scientific Advice with the EMA
- Data protection impact assessment
- IMPD development
To ensure that project results are correctly protected, can be exploited and are widely disseminated:
- IP strategy and FTO
- Technology development roadmap and feasibility studies
- Target Product Profile
- Development of an exploitation and business plan
- Commercialization Roadmap
- Development of training activities
- Data Management Plan
- Communication plan
Partners
Collaborators
