Core Viewpoint - The company, Weili Zhizhi Bo-B (09887), has successfully completed the first patient enrollment in the Phase II clinical trial of its self-developed GPRC5D/CD3 bispecific antibody, LBL-034, which is expected to be the first domestically targeted TCE therapy for GPRC5D [1] Group 1: Clinical Trial Details - The Phase II clinical trial (CTR20232974) is a multicenter, single-arm, and multi-cohort study led by Professor Lu Jin from Peking University People's Hospital, involving over 20 hospitals nationwide [1] - The trial aims to evaluate the efficacy and safety of LBL-034 in patients with various relapsed/refractory plasma cell tumors [1] Group 2: Product Characteristics - LBL-034 features a unique 2:1 structural design for the GPRC5D/CD3 bispecific antibody, which optimizes anti-CD3 affinity and spatial steric hindrance, significantly reducing the risk of non-specific T cell activation while maintaining effective T cell conditional activation [1] - The product demonstrates strong anti-tumor activity and improved safety, positioning it as a potential best-in-class therapy [1] Group 3: Previous Clinical Research Findings - In the previously conducted Phase I clinical study, over 50 enrolled patients showed good safety and efficacy across doses ranging from 80-1200 μg/kg, particularly at high doses where it exhibited CAR-T-like efficacy without additional safety risks [1] - Notably, patients with extramedullary tumors also showed significant efficacy and good safety, with a minimal residual disease (MRD) negative rate significantly higher than current standard treatments [1]
临床开发全面提速！维立志博-B(09887)TCE双抗Ⅰ期疗效比肩CAR-T，Ⅱ期首例患者成功用药