Barcelona, February 8, 2026
CAR-T Therapy Access Gets a Boost: A Mediterranean Network Takes Shape
Table of Contents
A new project aims to dramatically expand access to cutting-edge cancer treatment across Southern Europe, North Africa, and the Middle East.
- A €2.5 million initiative, Milenari, is building a decentralized network for CAR-T cell therapy production.
- The project focuses on making these personalized cancer treatments available to more patients in the Mediterranean basin.
- Regulatory hurdles remain the biggest challenge, but the project hopes to gain approval from the European Medicines Agency (EMA).
- The effort could serve as a model for expanding access in regions where CAR-T therapy is currently limited.
For patients battling certain blood cancers, CAR-T cell therapy offers a remarkable, often life-saving, option. But access remains shockingly limited. Currently, only about 4% of the world’s population in countries where it’s commercially available can actually get it. A new project, Milenari, is attempting to change that, particularly for those in the Mediterranean region. The initiative aims to make CAR-T therapy more widely available by establishing a network for decentralized production of these complex, personalized treatments.
A Collaborative Approach to Personalized Medicine
The Milenari project, funded with almost €2.5 million – 89% from the European Union Interreg Next Med program – is led by the Clínic Barcelona Research Foundation-August Pi i Sunyer Biomedical Research Institute (Clinic Barcelona-IdiBaps). The consortium includes the Clinical Hospital of Barcelona, the American University of Beirut (Lebanon), King Hussein Cancer Center (Jordan), and the Bambino Gesù Children’s Hospital (Italy). “The idea arises from the development of academic CAR-T therapies, which can be a therapeutic option for many people,” explains Dr. Manuel Juan, head of the Immunology service at Hospital Clínic Barcelona-Idibaps. “To make these products accessible, academic development needs collaboration between centers.”
Unlike the traditional industrial model, which relies on centralized manufacturing, Milenari champions a “patient-side” approach. Each CAR-T therapy is currently manufactured for an individual patient, meaning samples shouldn’t have to travel long distances to a single production facility. The project aims to demonstrate that centers in Jordan and Lebanon can produce therapies equivalent in quality to those created in more experienced facilities like those in Barcelona and Rome.
While the technical aspects of maintaining product quality across multiple centers are being addressed, the biggest hurdle is regulatory. In Europe, academic institutions can already produce these therapies for their own patients, but a network model requiring shared responsibility needs broader acceptance. The situation is even more complex in countries like the United States, where only pharmaceutical companies are authorized to manufacture drugs.
“Quality is demonstrated by proving that products are equivalent, while efficacy is validated in clinical trials,” Dr. Juan notes. “Although we are talking about personalized products, they are considered the same medicine because they are produced with the same release criteria and standards.” A key component of the project involves the Hospital Clínic of Barcelona manufacturing lentiviral vectors and distributing them to the other four centers for local CAR-T production.
What percentage of patients in Spain currently have access to CAR-T therapy? Approximately 27% of eligible patients in Spain have access to CAR-T therapy, a significantly higher rate than the global average of 4%, but still leaving 70% without access.
Expanding Access and Securing Approvals
Milenari’s ultimate goal is to achieve authorization from the European Medicines Agency (EMA), similar to that granted to commercial products. The project has already received a Prime (Priority Medicine) designation, which aims to expedite the approval process. Success could pave the way for broader distribution throughout Europe and potentially even to centers in Jordan and Lebanon.
The project’s impact won’t be limited to Europe. The team plans to share scientific evidence with governments in Mediterranean countries to encourage improved access. Regulatory pathways vary – some countries accept recommendations from the EMA or the Food and Drug Administration (FDA), while others rely on their own agencies. In fact, the product has already been authorized in India after submitting data to its regulatory agency.
The Milenari project represents a significant step toward democratizing access to this potentially life-saving therapy, offering hope to patients across the Mediterranean and beyond.
