Core Viewpoint - WuXi AppTec's CAR-T therapy, Relma-cel, has submitted Phase I study data for treating adult patients with active systemic lupus erythematosus (SLE) to the National Medical Products Administration (NMPA) in China, indicating significant potential for this innovative treatment in a challenging therapeutic area [1][4]. Group 1: Study Overview - The Phase I study is a multicenter, open-label, dose-exploration trial designed to assess the safety and efficacy of Relma-cel in SLE patients, with doses set at 50×10^6, 75×10^6, and 100×10^6 CAR+T cells [1]. - As of July 2025, a total of 12 female patients have been enrolled, with a median age of 27 years and a median disease history of 9.5 years [2]. Group 2: Patient Characteristics - All enrolled patients exhibited moderate to severe active SLE, with a median SELENA-SLEDAI score of 10 [2]. - 100% of patients had renal involvement, and other affected systems included skin (50%), hematologic (50%), and joints (16.7%) [2]. Group 3: Efficacy Results - Among the 12 patients evaluated for 6-month efficacy, 100% achieved SRI-4 response, and 50% met LLDAS criteria, indicating promising therapeutic effects [2]. - Various disease activity scales showed a downward trend, suggesting significant efficacy of Relma-cel in managing SLE [2]. Group 4: Safety Results - Initial safety results indicated that 11 out of 12 patients experienced grade 1 cytokine release syndrome (CRS), with one patient experiencing grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) [3]. - No dose-limiting toxicities (DLT) were reported, highlighting the favorable safety profile of Relma-cel in this patient population [3]. 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]. - The company anticipates further discussions with regulatory authorities to expedite the Phase II pivotal study, aiming to provide a breakthrough treatment option for SLE patients [4].
药明巨诺-B(02126)：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