The non-viral site-specific integration CAR-T technology platform addresses the potential tumorigenic risks caused by viral vectors in existing CAR-T products. Using this platform technology combined with electroporation delivery, the CAR structure is precisely integrated into the PD-1 locus of T cells, achieving a dual effect equivalent to a combination of PD-1 inhibitor and CAR-T. The non-viral targeted integration CAR-T platform has three core advantages: high safety, with no tumorigenic risk from random viral insertion; high manufacturing efficiency, significantly reducing the production cycle from 2-3 weeks for virus-based CAR-T with substantially improved cell uniformity; and significant cost advantage, given its use of non-viral processes and domestically sourced reagents, resulting in lower production costs compared to marketed CAR-T products, thereby allowing broader and more accessible cell therapy for patients.

The platform has high scalability and design flexibility. Its targeted integration strategy is not limited to PD-1, but can also be directed to other immune checkpoint or functional gene sites, providing an open and customizable technical foundation for developing next-generation immune combination-enhanced CAR-T products and can be used for the development of a broader range of immune-enhanced CAR-T products.