Cell therapies, such as CAR T-cell therapy, are on the rise. They act by changing the child's immune-cells in the cleanrooms to target cancer. The therapy clears away cancer cells and leaves healthy cells alone. Clean rooms are needed to make CAR T-cell therapy for children with cancer, as the cells need to be carefully manipulated without external contamination.
Currently, CAR T-cell therapy is a treatment for children with acute lymphatic leukemia (ALL) in whom other therapies no longer work. Máxima scientists will also be able to use the clean rooms for clinical translation of ongoing research to make cell therapy available to more and more children with cancer.
Strict rules
Dr. Adeel Saleem is head of the cell therapy facility and explains what it's like to work in a clean room: 'In the clean room, so-called GMP rules apply. This stands for Good Manufacturing Practice. These strict rules ensure that the production conditions are super clean so that the therapy meets all quality and safety regulations. We therefore work with a specialized team that will guarantee the quality and production of advanced cell therapies.'
Building these types of special rooms is a precise job that involves numerous quality controls. 'We work with specialized companies that help us with this. Together we try to set up the process as efficiently as possible. From building walls and work tables to connecting equipment and airlocks to change into.'
After construction, inspectors will check the facility in the first part of next year to make sure all conditions and processes are optimal for production. After a positive validation it is expected that the cell therapy facility will open in the second half of 2024.
Research and clinical trials
In addition to making the treatment in-house, the facility also accelerates research into new applications of CAR-T. A lot of research is being done on this at the Máxima and beyond.
CAR-T specialist and Máxima affiliated research group leader Dr. Claudia Rössig focuses on the application of CAR-T in so-called solid tumors, such as neuroblastoma and bone tumors. 'In the laboratory we are achieving hopeful results. As a result, we are already looking ahead to a possible time when studies with CAR-T cells in children with solid tumors can start. To make CAR-T cells available for clinical studies in pediatric cancer centers, they must be made in-house. With this facility, Máxima can not only provide CAR-T cells for our own patients and research. If necessary, it can also do so for other hospitals across Europe. And that is important if we start larger international clinical studies.'
Take a look?
Interested in how construction of the clean rooms is progressing? Then check out the photos.
Curious about how cell therapy, and CAR-T in particular, works? Watch the video here.
