Radboud university medical center has been granted a license to manufacture genetically modified immune cells for use in cancer treatment. The license follows a successful inspection by the Dutch Health and Youth Care Inspectorate in March 2026. During the inspection, the regulator assessed whether Radboudumc meets all quality and safety requirements for the in-house production of these advanced therapies.
The license enables Radboudumc to manufacture CAR-T cells on site. CAR-T cell therapy is a treatment in which a patient’s own immune cells are genetically engineered to better recognize and attack cancer cells.
In-house manufacturing of CAR-T cells offers several important benefits. Most notably, production time can be reduced from four to six weeks to approximately seven days. This shorter turnaround time is particularly important for critically ill patients, including those with certain forms of lymphoma, such as B-cell lymphoma.
From regulatory approval to patient care
Following completion of the final validation tests of the manufacturing process, Radboudumc will be able to begin producing CAR-T cells independently. Manufacturing is expected to commence in the course of 2027.
Initially, the CAR-T cells produced in Nijmegen will be used in a large clinical trial led by the University Medical Center Groningen. In the longer term, the aim is to make these locally manufactured CAR-T therapies available as part of routine clinical care.
Preparing for the future
Gene-modified cell therapies are playing an increasingly important role in cancer treatment. In addition to T cells, other immune cells, such as natural killer (NK) cells, can also be genetically engineered to enhance their ability to recognize and destroy tumor cells.
This new license strengthens Radboudumc’s ability to further develop these innovative therapies. It enables the production of internally developed CAR-T and CAR-NK cell products for use in clinical trials and investigational medicinal product research, supporting the development of more effective, sustainable, and accessible treatment options for patients.
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