CAR-T therapy is a cutting-edge cancer treatment that involves transforming a patient’s own immune cells into weapons capable of identifying and destroying cancer cells. Although it is highly effective, it involves a complex and lengthy manufacture process which can only be carried out at a limited number of sites. This, coupled with the high price of treatment (including long hospital stays during the manufacture process), means that many patients do not have access to CAR-T therapy.
The situation today: a long and complex process
CAR-T (chimeric antigen receptor T) therapies are manufactured individually for each patient. The first step entails collecting white blood cells from the patient. These are then sent off to an accredited centre where the cells are modified to allow them to target specific proteins found only on the surface of the cancer cells. The modified cells are then tested and expanded before being returned to the hospital, where they are administered to the patient via infusion. The manufacture process typically takes four to six weeks, and during this time, patients require significant levels of monitoring, bridging therapy and care as their condition is at risk of deteriorating further. Furthermore, the delay between cell collection and administration means some patients may not be prescribed CAR-T therapy at all.
On the hospital staff side, every step in the process requires a lot of training and represents a huge workload, from collecting the white blood cells and preparing and sending them for manufacture, to caring for patients during manufacture and then handling and administering the CAR-T cells once they are ready.
EASYGEN: targeting a revolution in CAR-T cell manufacture
Now, new IHI project EASYGEN aims to revolutionise CAR-T cell manufacture by developing an automated, modular, point-of-care cell and gene therapy manufacturing platform that would allow hospitals to generate CAR-T cells on site. The device would automate all manual steps between blood cell collection and administration of the modified cells, cutting the manufacture time to 24 hours. For hospital staff, this would dramatically reduce the workload associated with CAR-T cell therapy. On the cost front, EASYGEN expects its device to cut the cost of treatment in half.
“EASYGEN unites physicians, researchers, and partner institutions across Europe to collaboratively deliver innovative, personalised therapies,” said EASYGEN principal investigator Sonja Steppan of Fresenius. “Automating patient-specific therapies, such as CAR-T, is essential to making these treatments more broadly accessible, especially in non-academic clinical environments.”
The EASYGEN device would allow any hospital that can carry out blood cell collection to manufacture CAR-T cells, making these promising treatments accessible to a much larger number of patients. Patients would also benefit immensely from the shorter manufacture time.
Meanwhile the modular nature of the device could allow it to be adapted to manufacture other types of cell therapy. This is significant as today, CAR-T cells are only used for blood cancers; EASYGEN aims to advance the development of next-generation CAR-T cells capable of targeting solid tumours such as prostate cancer.
EASYGEN will collaborate with a wide range of stakeholders to ensure regulatory compliance and, importantly, to manage the seamless integration of its device into hospital workflows.
Increasing efficacy and access while reducing costs
“EASYGEN will take us into a new era of CAR-T therapy, where products are made directly at the patient's bedside either in an in-patient or in an out-patient setting,” said the project’s academic co-lead, Ulrike Köhl of the Fraunhofer Institute for Cell Therapy and Immunology Leipzig. “This will leverage a new dimension for increasing efficacy, increasing access and reducing cost for this breakthrough treatment.”