Setting up a Chimeric Antigen Receptor T Cell Therapy Program: A Framework for Delivery from the Worldwide Network for Blood & Marrow Transplantation
Year: 2025
Type: article
Abstract: Chimeric antigen receptor T cell (CAR-T) therapy is a genetically engineered cellular therapy that is currently integrated into the management of hematologic malignancies. Institutions treating patients with CAR-T therapy need to establish a framework of delivery that covers all the main components of the patient journey including intake of patients into the program from referring centers, patient selection according to established eligibility criteria, apheresis, logistics, bridging therapy, infusion, and postinfusion care. A CAR-T therapy program, with its unique requirements, needs to be delivered by a multidisciplinary team. Prior to the establishment of the program, a well-structured business plan should be developed with a clear financial and/or reimbursement model. Consideration should be given to overall capacity and staffing requirements. Standard operating procedures and guidelines are vital for ensuring that quality standards are clearly defined and adhered to. Institutions should develop a research plan for CAR-T therapy that may incorporate not only industry-sponsored trials, but also in-house manufacturing of investigational CAR-T products. This report presents recommendations from a group of international experts, highlighting the priorities and considerations when developing a new CAR-T program.
Authors: Syed Osman Ahmed, Riad El Fakih, Mohamed A. Kharfan-Dabaja, Farhatullah Syed, Ghulam Mufti, Christian Chabannon, Damiano Rondelli, Mohamad Mohty, Ali A. Al Ahmari, Jordan Gauthier, Marco Ruella, Miguel-Angel Perales, Shahrukh Hashmi, Feras Alfraih, Sarah Ghorashian, Mohsen Alzahrani, Zubair Abba, Mickey Koh, Marcelo Pasquini, Annalisa Ruggeri, Laurent Garderet, Abdulwahab Albabtain, Daniel Weisdorf, Hildegard Greinix, Hadeel Samarkandi, Nada Hamad, Yoshiko Atsuta, Mehdi Hamadani, Parameswaran Hari, Navneet S. Majhail, Raffaella Greco, Hazzaa Alzahrani, Anna Sureda, Ibrahim Yakoub-Agha, Ali D. Alahmari, Dietger Niederwieser, Mahmoud Aljurf
Institutions: King Faisal Specialist Hospital & Research Centre, Alfaisal University, Mayo Clinic, Mayo Clinic in Florida, King's College London, Inserm, Aix-Marseille Université, Institut Paoli-Calmettes, University of Illinois Chicago, University of Illinois Hospital & Health Sciences System, Sorbonne Université, Pitié-Salpêtrière Hospital, Fred Hutch Cancer Center, University of Pennsylvania, Memorial Sloan Kettering Cancer Center, Mohamed bin Zayed University of Artificial Intelligence, University College London, King Abdulaziz Medical City, National Guard Health Affairs, Mayo Clinic Comprehensive Cancer Center (Florida), St George's Hospital, St George's, University of London, Health Sciences Authority, Medical College of Wisconsin, IRCCS Ospedale San Raffaele, University of Minnesota, Medical University of Graz, St Vincent's Hospital Sydney, Aichi Medical University Hospital, Froedtert Hospital, Sarah Cannon, Vita-Salute San Raffaele University, Institut d'Investigació Biomédica de Bellvitge, Institut Català d'Oncologia, Universitat de Barcelona, Université de Lille, Centre Hospitalier Universitaire de Lille, Institute for Translational Research in Inflammation, Leipzig University
Language: English
Topic: CAR-T cell therapy research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,650
OpenAlex ID: W4410618549