What are the regulatory issues and challenges in Europe to harmonise translation of CAR-T therapies from bench to bedside? EATRIS Partners in EURE-CART report their findings.
Launched in 2017, the EURE-CART Project, composed of 9 partners from 5 EU countries, proposed to investigate the challenges facing the translation of adoptive immunotherapy with autologous T cells products in the EU from bench to bedside for these must have therapies which hold the promise to effectively treat various cancer types. This project, composing several EATRIS ATMP institutions, involved the conducting of a multicentre, first-in-man Phase I/IIa clinical trial to demonstrate the safety and the efficacy of CAR-T cell immunotherapy in acute myeloid leukaemia and multiple myeloma.
The main expected impact of EURE-CART was to strengthen the leader role of the EU in translational research, to establish CAR T-cell immunotherapy as the ultimate personalised therapy for cancer and to create secure new jobs in the EU through the instalment of an unprecedented alliance between academia, industry and regulatory bodies.
EATRIS institution, Instituto Superiore di Sanita, who lead the regulatory WP for this project, have now published a white paper documenting the regulatory issues and challenges faced to harmonise this translation from bench to bedside for these must have therapies for patients. This comprehensive report represents the output of the regulatory work package of the EURE-CAR-T project describing the regulatory challenges faced by the Cell therapy investigators to bring a CD44v6 CAR-T cell therapy from the laboratory to patients highlighting areas where European harmonization is still to be achieved and suggesting possible ways to reach it. Please find this publication here for your review which represents a major contribution to the field of gene-modified cell therapy development in the EU. We congratulate the EURE-CAR-T project Team on their excellent work.