Cryopreserving solution for clinical-grade CAR-T cryopreservation and capable of being directly reinfused through intravenous infusion

Abstract

The invention discloses a cryopreserving solution for clinical-grade CAR-T cryopreservation and capable of being directly reinfused through intravenous infusion. The cryopreserving solution comprisesthe following raw materials: dimethyl sulfoxide, a glycerol fructose sodium chloride injection, an invert sugar electrolyte injection, a dextran 40 glucose injection, a hydroxyethyl starch 130 / 0.4 electrolyte injection, a vitamin C injection, a human serum albumin injection and a 0.9 % sodium chloride injection; the cryopreserving solution has the pH value of 6.8-7.0. When a formula for the clinical-grade CAR-T cryopreservation and capable of being directly reinfused through the intravenous infusion is used for cryopreserving CAR-T cells, the thawed cells and the thawed cryopreserving solutiondo not need centrifugation, resuspension, fluid exchange and other processes and can be directly reinfused through the intravenous infusion, so that the loss of cell varieties due to pollution in-vitro repeated proliferation of the CAR-T cells, or changes of cell morphologies and cell functions are effectively avoided, medical equipment can be also significantly simplified and the workload of medical workers can be reduced.

Description

technical field

[0001] The invention belongs to the fields of biotechnology application and medical technology, and in particular relates to a cryopreservation solution for clinical-grade cryopreservation of CAR-T and capable of direct intravenous injection and reinfusion. technical background

[0002] Cytotoxic T lymphocytes (CTLs) are the main anti-tumor effector lymphocytes in the body, but the killing activity of CTLs is limited by MHC-I protein complexes, which greatly reduces the therapeutic effect of CTLs. Therefore, in the late 1980s, researchers such as Gross proposed the concept of CAR-T cell adoptive immunotherapy. CAR cells are artificial receptors that mimic the function of T cell receptors. They are sequentially connected by the antigen recognition domain SCFV and a series of signaling domains of T cells. This type of T cells bypasses the major histocompatibility complex of conventional cellular immunity. (MHC) restriction, and then directly transmit the recog...