Shanghai Cell Therapy wins first China trial nod for non-viral vector CAR-T therapy



China-based Shanghai Cell Therapy Group Co., Ltd's BZ019, a non-viral vector cluster of differentiation 19 (CD19) chimeric antigen receptor T-cell (CAR-T) therapy, reportedly gained clinical trial approval from the National Medical Products Administration (NMPA). The indication is CD19-positive relapsed or refractory diffuse large B-cell lymphoma. The approval is hailed as a first for domestic CAR-T cell products in terms of a non-viral vector-based therapy entering into th clinical setting.

BZ019 makes use of a non-viral vector for transfections, in contrast with previous CAR-T cell therapeutics that have entered the clinic in China. CAR-T cells prepared using non-viral vectors have the potential to benefit from several advantages, including low toxicity and immunogenicity, lower cost of production, and good reproducibility, according to the company.


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