@article{Nassif Kerbauy_Preto de Godoy_Melo Alves Paiva_Tiemi Kondo_Keith Okamoto_Bonamino_2022, title={Preclinical studies using CAR-T cells.}, volume={3}, url={https://www.jbmtct.com.br/seer/index.php/jbmtct/article/view/154}, DOI={10.46765/2675-374X.2022v3n1p154}, abstractNote={<p>The therapy with genetically modified T cells to express chimeric antigen receptors (CAR) is a promising strategy for immunotherapy against cancer. CAR-T cells can specifically recognize antigens on the surface of tumor cells and then effectively kill those cells. Several researchers have presented the development of CAR-T cells for various hematological targets and the treatment of solid tumors. Quality control and preclinical evaluation of these products are essential to demonstrate their safety and efficacy and allow development to the clinical trial phase. This chapter will present relevant guidelines regarding pre-clinical research of CAR-T cell products.</p> <p>Preclinical research on cell therapy products should include <em>in vitro</em> and <em>in vivo </em>pharmacodynamics studies (antitumor activity), pharmacokinetics (proliferation, distribution, and persistence of CAR-T cells <em>in vivo</em>), and animal safety studies.</p>}, number={1}, journal={JOURNAL OF BONE MARROW TRANSPLANTATION AND CELLULAR THERAPY}, author={Nassif Kerbauy, Lucila and Preto de Godoy, Juliana and Melo Alves Paiva, Raquel and Tiemi Kondo, Andrea and Keith Okamoto, Oswaldo and Bonamino, Martín}, year={2022}, month={Apr.}, pages={154} }