Abstract

Chimeric antigene receptor-expressing T cells or so-called CAR-T cells or CAR-Ts represent a group of pharmaceuticals with a novel mechanism of action and is indicated for the treatment of some haematological malignancies. Unlike normal T cells, the CAR-T cells can recognize tumour antigenes independently of major histocompatibility proteins, making them more effective compared to normal T cells. CAR-T cells belong to the group of pharmaceuticals called advanced therapy medicinal products
(ATMP), a group of drugs that are regulatively placed under biological medicinal products. First CAR-T cells reached the EU market in 2018, and since April 2023, six CAR-T cell-based pharmaceuticals have held marketing authorisation in the EU. In
parallel to the fact that CAR-Ts are the most widely employed ATMPs to date, development in this field is very intense aiming to design CAR-Ts that demonstrate a higher benefit-risk ratio, as well as have the ability to treat solid tumours. This review addresses
the following topics: regulatory background of CAR-Ts, T-cells as the starting material of CAR-Ts, specificities of their manufacturing and the mechanism of action; in addition, some examples of the future scenarios of these drugs are given.