In the past decade, many clinical trials with gene- and cell-based therapies (GCTs)
have been performed. Increased interest in the development of these drug products
by various stakeholders has become apparent. Despite this growth in clinical studies,
the number of therapies receiving marketing authorization approval (MAA) is lagging
behind. To enhance the success rate of GCT development, it is essential to better
understand the clinical development of these products. Chimeric antigen receptor (CAR)
T cells are a GCT product subtype with promising efficacy in cancer treatment which
are tested in many clinical trials, but have not yet received MAA.