On October 16, 2025, Xunlu Bio announced that the internationally top-tier academic journal Cell published online the research results of its self-developed fully human BCMA-targeted CAR-T cell therapy, Equecabtagene Autoleucel, for the treatment of progressive multiple sclerosis (PMS). This study not only demonstrates, for the first time globally, the safety and efficacy of CAR-T cell therapy in treating progressive multiple sclerosis but also represents the first publication in Cell of research results on successful treatment of autoimmune diseases with BCMA-targeted CAR-T cell therapy, marking a significant scientific breakthrough in the field.
The article published in Cell is titled "Anti-BCMA CAR-T Cells in Progressive Multiple Sclerosis." This study is based on an investigator-initiated clinical trial (NCT04561557) led by Professor Wang Wei's team from the Department of Neurology, Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology.
This study enrolled 5 patients with progressive multiple sclerosis (PMS), including 1 patient with primary progressive MS (PPMS) and 4 patients with secondary progressive MS (SPMS). The average age of onset was 38.2 years, with a baseline mean EDSS score of 6.2. Following a single infusion of Equecabtagene Autoleucel, the following observations were made:
Significant Efficacy: All patients showed significant improvement in EDSS scores, 9-Hole Peg Test (9-HPT), and 25-Foot Walk Time (T25FW); oligoclonal bands (OCBs) in cerebrospinal fluid completely disappeared, with significant reductions in kappa free light chain (κFLC) levels; and MRI revealed no new or enlarging gadolinium-enhancing T1 lesions or T2 hyperintense lesions.
Favorable Safety Profile: 80% of patients experienced only transient Grade 1 cytokine release syndrome (CRS), with no Grade ≥2 CRS; no immune effector cell-associated neurotoxicity syndrome (ICANS) or other neurotoxic reactions were observed.