Rome, November 17 (Adnkronos Health) – More than 6 years after the arrival of the first anti-cancer gene therapy in Italy, Car-T (Chimeric Antigens Receptor T-Cells) – an advanced therapy based on the modification and enhancement of T lymphocytes, which in this way are able to recognize and attack tumor cells – is now a reality and is used in clinical practice in many centers in Italy. But the ‘journey to the future’ continues: the number of therapies in progress has increased from 35 in 2019 to 498 in 2024 and laboratories around the world continue to search for new and difficult to achieve targets. Car-T as we know it today is just the first step on an ever-evolving path, and there are still many questions to be answered. In this perspective, Ail – Italian Association against Leukemia, Lymphoma and Myeloma has decided to continue the ‘journey’ of ‘Car-T – The future is already here’, with the Florence stage. The meeting – the organizers explained in a note – began with an institutional welcome from Nicola Paulesu, councilor responsible for Welfare, Reception and Integration of the municipality of Florence. This travel and online campaign was born in 2021, to provide information to patients, family members, caregivers and specialists, as well as improve knowledge, access and treatment management, by looking at the clinical experience gained, the success of patients treated and future areas of application.
“The arrival of Car-T in Italy was long awaited and, when this therapy was finally available, raised many hopes and questions. Ail immediately felt the need to go to the field with clear and correct information: thus the campaign ‘Car-T – The Goal of the Future’ was born, designed with the aim of providing education about this innovative cellular therapy – says Giuseppe Toro, national president of Ail – The first edition of the campaign reaches 10 regions of Italy with 11 stages from the North to
South of the country, thanks to the support of the local Ail section”. The Association recognizes that the journey towards the future of Car-Ts continues: hence the decision to continue the ‘journey’ with this second edition of the initiative and 4 new stages. Although there are still many challenges to be faced for research and physicians and several important questions to be answered, Car-Ts represent more than a real hope for patients who do not respond to conventional therapy, and their use is achieving successes that were unexpected until a few years ago in patients who no longer had any therapeutic possibilities. In this exciting and rapidly evolving scenario – added Toro – Ail is determined to remain with patients and families and wants to continue to promote the most complete and correct information that can help patients and doctors themselves towards the safest and most effective therapeutic options”.
In Italy there are 5 approved Car-Ts, out of 6 approved in Europe, and with increasing indications in adults and children, and between 1,500 and 1,800 patients have been treated in approximately 44 authorized centers. “Car-T therapy is currently reimbursed in Italy – underlines Alessandro Maria Vannucchi, professor of Hematology, director of Sod Hematology, director of the Department of Oncology Aou Careggi, University of Florence, president of Sies – the Italian Society of Experimental Hematology – is used for some leukemias, such as acute lymphoblastic leukemia, for some aggressive lymphomas such as large B-cell lymphoma, mantle cell lymphoma and follicular lymphoma, and recently in multiple myeloma. Indications vary depending on the stage of the disease, the course of treatment previously undertaken, the patient’s age and fitness.”
A fundamental pillar for the development of Car-T cells is basic and clinical research in the field of immunotherapy. “Other, even more innovative therapies are in the pipeline – explains Monica Bocchia, professor of Hematology, department of Medicine, Surgery and Neurosciences, University of Siena; director of Uoc Hematology, Aou Siena – drugs capable of specifically inhibiting certain mutated genes, specific and targeted drugs that do not destroy leukemia cells, but through gene inhibition promote their normal differentiation and maturation. A new hope in older and fragile patients as they are less toxic than chemotherapy.”
Car-T cells represent an outstanding model of translational research. “It is important to understand why some patients do not respond adequately or why in some patients the disease relapses – observes Francesco Annunziato, full professor of General Pathology, director of the department of Experimental and Clinical Medicine, director, Sodc Flow Cytometric and Immunological Diagnostics, Aou Careggi, Florence – This knowledge process is defined as ‘reverse translation’, that is, we start from the basics to arrive at the clinical application, then we observe the clinical application to understand how to try to increase Car-T cells. This process accelerates the development of new treatments and improve existing treatments.”
The surprising results obtained in multiple myeloma reflect the consistent effectiveness of Car-T therapy. “Currently, with Car-T, survival can exceed 2-3 years, with cases of prolonged remission and MRD negativity – highlights Elisabetta Antonioli, medical director of Sodc Hematology, Aou Careggi Florence – However, a new organizational approach is needed for the care of these patients that must be multidisciplinary and for the structures that administer this Car-T, patients must be managed in centers accredited for cell manipulation and management of specific toxicities (Crs, Icans)”.
Some CAR-Ts “can already be used starting from second-line treatment, others from third- or fourth-line treatment, configuring an increasingly expanding therapeutic panorama”, said Benedetta Puccini, medical director of Hematology, Sodc Hematology, Department of Oncology, Aou Careggi Florence and Coordinator of the Multidisciplinary Oncology Group for Lymphoproliferative Diseases. “Such centers, both for children and adults – says Chiara Nozzoli, program manager of hematopoietic stem cell transplantation and cellular therapy, Sodc Hematology, Aou Careggi, Florence – in order to be authorized to administer CAR-T therapy, must have certain organizational and infrastructure requirements.” We can distinguish “two levels of the Car-T Team – explains Ilaria Cutini, medical director of Sod Hematology, Aou Careggi, Florence – The first is dedicated to the management of early post-infusion complications, consisting of transplant experts and intensivists. The second team intervenes at a more advanced stage of the process, and is oriented towards evaluating the response to treatment and determining the most appropriate follow-up path”. The cost of innovative immunotherapy “is certainly high – explains Sara Galimberti, full professor, department of Clinical and Experimental Medicine, University of Pisa; director of Uoc Hematology, Aou Pisana – It is important to guarantee equitable access across national territories and prescriptive suitability, taking into account not only the cost of the product, but also cost/effectiveness, as CAR-T currently represents a therapeutic opportunity that offers survival and a good quality of life for many patients”.
Currently “Ail Firenze has the possibility to welcome patients and their families free of charge in the 22 rooms of the Hospitality House named after Professor Rossi Ferrini, patients and their families treated at the Careggi and Meyer hospital centers – said Alberto Bosi, president of Ail Firenze, honorary full professor of Blood Diseases, University of Florence – From January to September 2025 we hosted around 7,300 people, with an average daily attendance of 27 people; from From 2010 to 2015, a total of more than 195 thousand attendances. Regarding research support, AukFirenze collaborates with the Chair of Hematology of the University of Florence, currently headed by Professor Alessandro Maria Vannucchi, and by 2025 we have contributed with support, to date, around 70,000 euros”.
The 2024-2025 edition of the ‘Car-T – The future is here’ campaign activity – ending the note – is carried out with the unconditional support of Bristol Myers Squibb, Gilead Sciences and Johnson&Johnson. This includes a dedicated landing page on the ali.it website while local events involve specialists, patients, carers, Ail volunteers and the media. The information activity is enriched with an oral video story, available on the campaign homepage, in which Andrea Grignolio, professor of History of Medicine and Bioethics at San Raffaele University of Milan – Cnr Ethics tells the path of discovery that led to a revolutionary approach in the treatment of tumors.
