Study of subacute toxicity of the drug "Carplasmin"

A preclinical study of subacute toxicity of the drug ‘Carplasmin’, which is a representative of the CAR-T group of drugs (T-lymphocytes with chimeric antigenic receptors), was conducted. ‘Carplasmin’ has tropism to cancer-embryonic antigen (CEA) and is able to lysis CEA-positive tumour cells. Subacute toxicity was investigated by intravenous administration on groups of outbred rats and on Chinchilla rabbits. To obtain CAR-T ‘Carplasmin’ the plasmid preparation in the dosage form ‘lyophilisate for preparation of solution for intravenous administration 1.2 mg’ produced by by HEMA LLC (Russia) was used. One dose of the preparation ‘Carplasmin’ (effective dose, ED) represented 1 million CAR-T lymphocytes.In the course of the study, it was shown that multiple intravenous injection of the preparation ‘Carplazmin’ in the dose of 10 ED has no toxic effect on white outbred rats except for insignificant short-term external signs of intoxication after injection. Also, no toxic manifestations were observed at a dose of up to 4 ED in Chinchilla rabbits. A slight increase in the total leucocyte content and changes in the leucocyte formula were observed in rats and rabbits receiving the maximum dose of the drug.