1

Why the project matters

While CAR T-cell therapy has transformed cancer care in parts of Europe, patients in countries like Lebanon and Jordan still face limited access. Centralized production models and high costs present barriers across the Mediterranean.
Currently, the manufacturing of CAR T-cells is organized in a setup that uses centralised manufacturing facilities. Due to their complex properties and limited lifetime, such centralised industrial production approach is economically unattractive and limits the efficient implementation and scale-up of new products. Moreover, developing medicines for rare diseases poses limited commercial incentives due to challenges in scale up production and serving a small patient group. The substantial upfront costs and complex registration and reimbursement procedures further discourage investment.
As a result, potential earnings from orphan disease therapies are inherently limited. Academic research centers are increasingly leading ATMP research and development, including early clinical trials, benefiting from their specialized resources and expertise.
MILenARI responds with a decentralized, collaborative model: lentiviral vector production will be scaled up in Spain and shared with facilities in Italy, Lebanon, and Jordan. Through knowledge transfer, training, and facility development, the project helps democratize access to advanced cancer therapies, strengthens regional research and innovation capacity, and prepares the ground for future clinical trials in underserved countries.

2

What it aims to achieve

• Increase the production capacity of lentiviral vectors in Spain, a key piece to manufacturing CAR-T.
• Share technology and training with Italy, Lebanon, and Jordan, to decentralize production and prepare these countries for future clinical trials.
• Establish the basis for an international clinical trial in pediatric patients with acute lymphoblastic leukemia, contributing to reducing health inequalities.

3

Expected change

• Increased regional capacity to manufacture and deliver CAR T-cell therapy through decentralized production sites and knowledge-sharing.
• Improved accessibility of advanced therapies for cancer patients in underserved regions, especially children with acute lymphoblastic leukemia.
• Strengthened collaboration between researchers, hospitals, and regulatory bodies across the Mediterranean, paving the way for clinical trials and future approvals.

4

What the project delivers

• Industrial-scale lentiviral vector production process and validation in Spain.
• Regulatory compliance framework and export agreements for cross-border vector distribution.
• Establishment and certification of new CAR-T manufacturing facilities in Lebanon, Jordan, and Italy.
• Production and quality control of research-grade CAR-T cell therapy batches.
• Preparation of clinical study documentation for future pediatric trials.
• Knowledge transfer, capacity building, and hands-on training for clinical and technical teams.

5

Who benefits

• 100+ cancer patients annually across Lebanon, Jordan, Italy, and Spain gaining improved access to CAR T-cell therapy.
• 4+ hospitals (Research Foundation Clínic Barcelona/Hospital Clinic of Barcelona in Spain, Ospedale Pediatrico Bambin Gesú in Italy, American University of Beirut in Lebanon, King Hussein Cancer Center in Jordan) equipped and trained to produce and deliver CAR T-cell therapy locally.
• 50+ healthcare professionals trained in CAR T-cell manufacturing, clinical use, and regulatory processes.
• 4 national regulatory authorities involved in aligning procedures for future clinical trial approval and product registration.
• Research and academic institutions enhancing cross-border research output and expertise through technology transfer and clinical collaboration.
• Lentiviral vector producers and biotech partners benefiting from improved manufacturing scalability and access to new regional markets.