Core Viewpoint - WuXi AppTec's subsidiary WuXi Biologics has submitted data for the Phase I study of Relma-cel in adult patients with active systemic lupus erythematosus (SLE) to the National Medical Products Administration (NMPA) in China, marking a significant step in the development of CAR-T therapies for autoimmune diseases [1][4] Group 1: Study Overview - The Phase I study is a single-arm, open-label, multi-center, dose-exploration trial aimed at assessing the safety of Relma-cel in SLE patients, with an initial dose set at 50×10^6 CAR+T cells [1] - The study has enrolled 12 participants as of July 2025, focusing on safety, efficacy, pharmacokinetics, and pharmacodynamics across three dose levels: 50×10^6, 75×10^6, and 100×10^6 CAR+T cells [1][4] Group 2: Patient Demographics and Baseline Characteristics - All 12 enrolled patients were female, with a median age of 27 years and a median disease history of 9.5 years [2] - The patients exhibited moderate to severe active SLE, with 100% having renal involvement and other common organ systems affected including skin (50%) and hematologic systems (50%) [2] Group 3: Efficacy Results - Among the 12 patients evaluated for 6-month efficacy, 100% achieved SRI-4 response, 50% met LLDAS criteria, and 100% were drug-free [2] - Various disease activity metrics, including SLEDAI-2K and SELENA-SLEDAI scores, showed a downward trend, indicating significant therapeutic effects [2] Group 4: Safety Results - Initial safety results indicated that 11 out of 12 patients experienced grade 1 cytokine release syndrome (CRS), while one patient experienced grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) [3] - No dose-limiting toxicities (DLT) were reported, suggesting a favorable safety profile for Relma-cel in treating moderate to severe active SLE [3][4] Group 5: Future Prospects - The ongoing study aims to gather longer follow-up data, with the potential for Relma-cel to advance to the biologics license application (BLA) stage [4] - As the first commercial CAR-T therapy approved for clinical trials in the SLE treatment space, Relma-cel demonstrates significant potential for providing breakthrough treatment options for SLE patients [4]
药明巨诺-B：已向国家药监局递交瑞基奥仑赛在中国成人活动性系统性红斑狼疮患者中的I期研究数据