Cell and gene therapies are at the very centre of healthcare innovation and are responsible for a paradigm shift in the treatment of many diseases. European research institutions contribute significantly to the development of such therapies, yet the number of cell and gene therapies that are introduced to the market remains limited. Current EU regulatory frameworks are not fully adapted to the specificities of these new therapies, thereby challenging optimal patient access and sustainability of these innovative products within European healthcare systems. To tackle this challenge, EUHA founded the European Centre for Gene and Cellular Therapies (EUCCAT), a virtual centre that brings together basic research groups, medicinal production facilities, and clinical trial capacity to accelerate translation of research into real cellular treatments for large cohorts of patients. In 2022, several EUHA members, through EUCCAT, proposed to launch a cross-border decentralised pilot study (the so-called MC2 TCR-T trial) to treat cancer patients with gene-engineered cells. As a result, a therapy developed at Erasmus MC for an aggressive form of skin cancer is now scheduled to cross borders and tested at two other EUHA hospitals: Charité – Universitätsmedizin Berlin and Assistance Publique – Hôpitaux de Paris . The results of this pilot are expected to identify lessons and support necessary practices towards clinical development of new cellular therapies across Europe. This joint effort brings together teams across EUHA and EUCCAT, including those of prof. dr. Reno Debets at Erasmus MC, prof. dr. Annette Künkele at Charité, and prof. dr. Celeste Lebbé at Assistance Publique – Hôpitaux de Paris . Reno Debets, who heads the Tumour Immunology Laboratory at Erasmus MC and is a member of the EUCCAT Working Group, and his team developed the Advanced Therapy Medicinal Product (ATMP) used in the study.The therapy relies on living TCR-T cells — immune cells derived from the patients themselves and engineered to recognise and attack skin cancer.In a conversation with EUHA, Reno shared insights into the opportunities and challenges of bringing cellular therapies to patients across Europe. European Collaboration: Making Therapies Competitive, Affordable, and Accessible In a single country, a relatively low number of patients are eligible for this cellular medicine. Furthermore, the treatment is complex and expensive, making it difficult to scale up production. At a European scale, however, the patient numbers are larger, and expertise can be pooled. Collaboration, therefore, is a natural fit.Reno highlighted the need to break down existing barriers. While Europe is strong in the development of ATMPs, their translation into patient care remains limited compared to the United States and China. He noted that these countries benefit not only from access to larger patient populations but also from less fragmented regulations, enabling faster market access for ATMPs. In contrast, Europe remains constrained by national borders, making it difficult to scale up and implement therapies across multiple countries. As a result, promising products risk remaining in early clinical phases and reaching too few patients. According to Reno, European collaboration significantly contributes to the solution. “EUHA hospitals collectively have a huge cohort of patients, even for the rare and ultra-rare diseases. This is not only beneficial for the cost-effectiveness of cellular treatments, but also for the path to market introduction and patient accessibility. Not to mention, through this network, we can share best practices regarding regulation and technology, which ensures the necessary acceleration to patient care. Through EUCCAT, we’re now for example working to bridge regulatory gaps, both in the areas of cellular products, intellectual property and technology transfer. This would then enable the exchange of new medicines as well as their production and distribution.”Reno Debets “Initially, with this scenario, we could treat 15 patients per year. In the next years, we could then scale up to treating a few hundred and ultimately to about 500 patients across multiple European countries. To this end, we have to change to decentralised, on-site production of TCR-T cells, first in the Netherlands, France, and Germany, and subsequently in other European countries. It’s really great to see how everyone involved, including clinical oncologists, pharmacists, scientists, as well as lawyers from all three EUHA sites, is enthusiastically collaborating towards this pilot.” Reno Debets Through a multi-step up-scaling, EUHA aims to facilitate the introduction and access to academically developed cell and gene therapies. A Cross-border Pilot Study Providing the cellular therapy against skin cancer developed by Erasmus MC to patients in three countries is a promising pilot project to roll out ATMPs on a more European scale. The intention is that the project begins with the centralised production of TCR-T cells for Dutch, French, and German patients at Erasmus MC. For this purpose, the hospitals will send immune cells from their patients to Erasmus MC. The immune cells will then be processed into an ATMP and returned to the hospitals where the patients are treated. A Paving the Way for Cellular Therapies in Europe In this pilot study, patients at Assistance Publique – Hôpitaux de Paris and Charité – Universitätsmedizin Berlin will also be treated with the ATMPs produced at Erasmus MC. EUCCAT’s ambitions extend further. The skin cancer pilot serves as proof-of-concept study to better streamline the clinical development of more ATMPs in Europe. EUCCAT and EUHA are very proud of this first cross-border decentralised clinical trial in EUHA members. It is a demonstration of EUHA’s mission ‘to lead by doing’. The perseverance and the mutual trust between the teams in Erasmus MC, Assistance Publique – Hôpitaux de Paris and Charité – Universitätsmedizin Berlin has made this possible. They all deserve our sincere thanks for this achievement. EUCCAT thus offers a unique and effective platform to remove barriers and help spread new cellular therapies across Europe. Reno Debets For more information, please visit this page.