Bologna Hematology Leads the Way in Italy with 240 Patients Treated with Car-T

Nationally and internationally recognized as an excellence in the treatment of blood tumors, Bologna's Hematology department confirms its position at the forefront. The Institute of the Sant'Orsola Polyclinic Irccs named after 'Lorenzo and Ariosto Seràgnoli' embraces the great legacy of the hematologist Sante Tura, continuing the path he traced, as a generator of clinical research and administration of Car-T cell therapy, the most innovative and promising frontier in the fight against blood tumors. "The best is yet to come", underlined the specialists of the Bologna Oncohematology gathered for a discussion promoted today in Bologna by Ail - Italian Association against leukemia, lymphomas and myeloma on the topic 'Car-T Cells, results and perspectives in blood tumors', which precedes the opening of the Hematology Summit (13-15 May), an international meeting sponsored by Sie - Italian Society of Hematology and which will see the presence of over 60 of the major international experts in the various oncohematological pathologies.

The Institute of Hematology 'L. e A. Seràgnoli' Irccs Azienda ospedaliero-universitaria di Bologna - reports a note - is a leader in the use of Car-T therapies in Italy with 240 patients treated (190 lymphomas, 46 myelomas and 4 acute lymphoblastic leukemias) and with more than 240 clinical trials, a third of which on lymphomas, with experimental phase 1, phase 2 and phase 3 drugs. Furthermore, the cell factory for the academic production of new advanced cellular therapies is almost complete in the center. "When we started, more than 5 years ago, the Car-T Centers authorized to administer these cellular therapies were no more than 5-6: today they are over 40 - says Pier Luigi Zinzani, professor of Hematology Alma Mater Studiorum, University of Bologna, director of the Institute of Hematology 'L. and A. Seràgnoli' and president of Sie - We have been leaders in the use of Car-T. Over 40% of the patients we see come from outside the region and this is because for many years we have been the center in Italy with the highest number of clinical trials of experimental drugs in phase 1, 2 and 3, so we give the possibility, especially to those patients who do not respond to conventional therapies, to be treated with innovative experimental drugs".

"Hematology in Bologna - adds Zinzani - has grown exponentially over time in the field of innovative clinical research, healthcare and also in pure research, but this is due to the work of Professor Sante Tura who, together with Professor Franco Mandelli, represent the undisputed founding fathers of modern Italian hematology. Two characters of great depth, two great medical profiles, two visionaries who were already in the future when others were still in the present. I thought it right and proper to dedicate the Hematology Summit to the memory of Professor Sante Tura, to remember his legendary figure, the mark he left, his strength, his far-sighted vision".

In the last 5 years, the list of Car-T indicated for some blood tumors has grown: to date there are more than 11 and phase 1 studies are starting for the second generation of autologous Car-T, those that are produced with the patient's own T lymphocytes - the note continues - but several studies are also underway for the production of allogeneic Car-T, produced from healthy donors or from pluripotent stem cells. Much still remains to be done: broaden the indications, anticipate the use in the first lines, reduce toxicity, shorten production and hospitalization times, increase potency and duration at lower doses, reduce production and manufacturing costs. The Sant'Orsola project to create a cell factory, the first in Emilia Romagna, for the production of academic Car-T, that is, produced in a hospital/university setting for non-profit purposes and within clinical studies, fits into this complex and exciting scenario.

"The cell factory is in the final phase of its construction and is supported by clinical and preclinical translational research of new constructs - explains Francesca Bonifazi, director of the Complex Unit of Transplantation and Cellular Therapies, IRCCS AOU of Bologna - IRCCS Sant'Orsola has invested heavily to realize this project that began in 2022 with a research platform called the Laboratory of immunobiology of transplants and cellular therapies (IBT). Our goal is to produce new academic Car-T and to find new indications, possibly more effective, and that can also be used for blood diseases that are not attractive to pharmaceutical companies. The ongoing collaboration with Professor Franco Locatelli of Bambino Gesù in Rome for research on Car-T products is important, with whom we will work as soon as we are ready to share some studies with academic Car-T".

The Sant'Orsola Polyclinic became an IRCCS in 2020 following the recognition obtained in the fields of assistance and research in transplants and critical patients, as well as for the integrated medical and surgical management of oncological pathologies. In recent years, scientific research activity has been greatly strengthened thanks also to the greater ability to attract funding. In 2023, funds allocated to scientific research reached almost 30 million euros, 63% more than in 2022 and more than triple compared to 2021. "The balance can only be extremely positive - says Chiara Gibertoni, general director of the IRCCS Aou of Bologna, Sant'Orsola Polyclinic - with a further turning point for an excellence already recognized among the best at national and international level, in particular for the development of pioneering sectors such as Car-T".

"Synergies - continues Gibertoni - have developed mainly in two directions: participation in European research networks and collaboration with other IRCCS and Italian universities. At a European level, we are actively involved in programs such as Horizon Europe and EU4Health, which allow us to work on innovative projects in the health and technology fields. Furthermore, we are part of the European Reference Networks (ERN), which allow us to share knowledge and skills on rare and complex diseases. It is essential to guarantee innovation within public structures, because medicine without innovation and research cannot keep up and provide adequate care for citizens' needs. We must be able to follow the new paths of medicine with conviction. Advanced cell therapies, in this sense, are a perfect example".

For over half a century, Ail has been alongside patients and their families and supports scientific research to offer patients the best possible care, supporting them with the work of 17 thousand volunteers spread across the country and the 83 provincial sections. Car-T are a great opportunity for onco-hematological patients, which is why rigorous information is essential. "Car-T - highlights Giuseppe Toro, national president of Ail - represent more than a concrete hope for those patients who do not respond to conventional therapies and their use is obtaining unexpected successes in patients who no longer had any therapeutic possibility, after having tried all available treatments. There are still many challenges to be faced for research and for clinicians. Ail, in this constantly evolving scenario, is alongside patients and families, promoting information that is as exhaustive and correct as possible that is able to help patients and doctors towards the safest and most effective therapeutic choices".

The Ail Bologna section is active with a wide network of free services: home hematological care that in 2024 alone allowed 197 people to be assisted and more than 16,500 services to be performed, with an investment of half a million euros; the Casa Ail, essential for patients who are following experimental therapies or are treated with Car-T, in 2024 hosted 391 patients and over 6,500 presences; psychological support with 293 people for a total of 1,400 interviews and then, among other services, shuttle transport with more than 1,100 home-hospital accompaniment trips. Finally, the many volunteers who work within the Seràgnoli in the reception, triage, day service and hospitalization wards areas. "Ail Bologna - underlines the president, Gaetano Bergami - invests with determination in scientific research. During 2024 it has allocated 1,215,402 euros to support 44 projects focused on the main onco-hematological pathologies. The investment has made it possible to finance 44 research professionals, including 14 biologists and biotechnologists, 16 data managers, 7 doctors, 6 dedicated nurses and 1 laboratory technician. A strategic commitment has been dedicated to the cell factory project, a new generation infrastructure for the production of advanced cellular therapies, which represents a decisive step towards therapeutic innovation and personalized medicine. Through this effort, Ail Bologna confirms its active role in assistance and scientific innovation as a reliable ally in building a future in which blood tumors can one day be cured".