GN001

GN001 (also referred to as GI001 or GI-001) is an investigational, in vivo CD19-targeted chimeric antigen receptor (CAR) T-cell therapy being developed by Shanghai Fengxun Biotechnology (DeliNova Therapeutics) in collaboration with clinical institutions such as Pu'er People's Hospital. Unlike traditional ex vivo CAR-T therapies that require complex, costly, and time-consuming cell extraction, genetic modification, and expansion outside the body, GN001 is designed to generate CAR-T cells directly within the patient's body. It utilizes a third-generation, self-inactivating lentiviral vector system with a five-plasmid packaging design to deliver the CD19 CAR gene directly to endogenous T cells via intravenous infusion. This in vivo approach aims to eliminate the need for ex vivo cell manufacturing and toxic lymphodepleting preconditioning chemotherapy, potentially reducing treatment costs and improving patient accessibility. GN001 is being evaluated in Phase 1 clinical trials for the treatment of patients with CD19-positive relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) and B-cell acute lymphoblastic leukemia (B-ALL).