Shanghai Cellular Therapy Group Advances China's First Non-Viral CD19 CAR-T Therapy BZ019 into Clinical Trials

On April 11, Shanghai Cell Therapy Group received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for its novel CAR-T cell therapy drug targeting CD19, “Non-viral Vector CD19 CAR-T Cell Injection (BZ019).” The therapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that is CD19-positive, including primary mediastinal large B-cell lymphoma and transformed follicular lymphoma. This marks the first non-viral vector-based CAR-T cell therapy product approved for clinical development in China.

BZ019 differs from previously approved CAR-T cell products in that it employs non-viral vectors for transfection, rather than lentiviral or retroviral vectors. According to the official WeChat account of Shanghai Cell Therapy Group, compared with viral vector systems, non-viral vector systems offer simpler manufacturing processes and easier quality control. In terms of storage, the plasmid DNA used in non-viral vectors exhibits higher stability, has less stringent storage requirements than the RNA viruses in viral vector systems, and boasts a longer shelf life. Furthermore, the cost of non-viral vectors during the transfection step is only one-tenth that of viral vectors. Consequently, under identical production conditions, CAR-T cells manufactured using non-viral vector systems can achieve significant cost savings.

Meanwhile, according to the official WeChat account, viral vector transfection systems use inactivated HIV for CAR gene transfection, which carries a risk of viral re-replication. Therefore, the FDA recommends follow-up monitoring of treated patients for up to 15 years to ensure safety. In contrast, non-viral vectors do not pose such concerns and are theoretically safer. Furthermore, because CAR-T cells produced using non-viral vectors have a higher proportion of memory T cells, the incidence of cytokine storm during treatment is lower, resulting in improved safety.

Currently, cell therapy technologies represented by CAR-T have become biologicalPharmaceuticalsAs one of the most promising sectors in the industry, CAR-T therapy research continues to achieve new breakthroughs. Countries worldwide are steadily increasing their investments in this field, while the commercialization and industrialization models of CAR-T have also become a key focus of industry attention. Currently, CAR-T cell manufacturing still relies on traditional manual operations, making it challenging to ensure production cost-efficiency and product consistency. However, with advancements in automation and artificial intelligence, CAR-T technology is expected to undergo further optimization in the future, thereby providing patients with more cost-effective treatments.