This regulatory milestone marks a significant expansion for the Rockville and Shanghai-based firm, which is already testing the therapy in patients with systemic lupus erythematosus. The trial aims to evaluate the safety and efficacy of C-CAR168, an autologous treatment that targets both CD20 and BCMA to achieve deep depletion of disease-driving B cells and plasma cells. By resetting the immune system, researchers hope to address the underlying dysfunction that causes irreversible neurological decline in progressive multiple sclerosis.

Tony (Bizuo) Liu, Chairman and CEO of AbelZeta, stated that the company remains optimistic about the therapy’s potential based on preliminary data. Early observations from a first-in-human study showed that two patients with secondary progressive multiple sclerosis experienced functional improvements and sustained reductions in their Expanded Disability Status Scale scores following treatment. The upcoming study will recruit between 6 and 24 patients for the initial Phase 1b dose-finding stage, followed by a larger Phase 2 cohort of approximately 95 participants across two independent groups. The trial will focus on individuals with active and non-active progressive disease, addressing a critical need for therapies that can stabilize conditions currently lacking effective treatment options.