Investigation of the acute toxicity of the new anticancer drug "Karplazmin-OVA" intended for CAR-T therapy of CEA-positive tumors

The aim of the study was to determine the safety parameters in acute toxicity studies of a new somatic cell antitumor agent for CAR-T therapy of solid tumors expressing cancer embryonic antigen (REA) - Karplazmin-ova. The investigated somatic cell drug is an autologous T-lymphocyte genetically modified with recombinant plasmid DNA carrying the REA gene. The study of acute toxicity of the drug was conducted in 168 white mongrel mice (84 males and 84 females), 168 white mongrel rats (84 males and 84 females) and 30 Chinchilla rabbits (15 males and 15 females). The study of acute toxicity of the drug involves a single administration of a pharmacological substance and further observation of the experimental animals for 14 days. Based on the conducted studies, it has been shown that the drug has no pronounced toxic effect on experimental animals.