The project has just launched the phase that frames the regulatory foundations for its future CAR-T clinical trials across the four Mediterranean countries involved.
MILenARI has launched a new phase dedicated to establishing the regulatory and operational foundations required for its future CAR-T clinical trials. Part of the final phase of the project, the trials are expected to happen across the four Mediterranean countries that are part of its consortium: In Italy, they will be led by the Bambino Gesù Children’s Hospital; in Lebanon, by the American University of Beirut; in Jordan, by the King Hussein Cancer Center; and in Spain, by the institution that coordinates the project, Clínic-IDIBAPS.
With the official kick-off of this work package, led by Bambino Gesù Children’s Hospital in April 2026, MILenARI enters a key phase focused on defining the foundations needed to enable future CAR-T clinical trials at the end of the project, while supporting the transition from advanced manufacturing processes towards clinical application across a coordinated Mediterranean framework.
The key focus detected at this early stage is the difference between countries, regarding the regulatory landscape. Partners have worked to map and compare the different national frameworks, identifying barriers that may affect the implementation of its future clinical trials. This analysis is essential to ensure that the planned consequent phases can be easily conducted across all participating countries.
During the start of this phase, it was clear that partners are now learning how to navigate the complexity of advanced therapy regulation in diverse national contexts. Something that adds to the existing and challenging geopolitical environment, which may impact the development of the project and the implementation of activities in some regions. In particular, the partner in Lebanon faces serious constraints due to the ongoing war on the region.
With this kick-off, the project reinforces its ambition to build a sustainable, transnational framework for CAR-T development, ultimately contributing to more equitable access to advanced therapies across the Mediterranean region.
Last Update
07/05/2026
Next Med