智通财经APP获悉，8月25日，维立志博-B(09887)宣布，公司自主研发的GPRC5D/CD3双特异性抗体顺利完成Ⅱ期临床研究（CTR20232974）首例患者入组，有望成为首个国产靶向GPRC5D的TCE疗法。该研究是一项多中心、单臂、多队列Ⅱ期临床试验，由北京大学人民医院路瑾教授牵头，全国20余家医院共同参与，旨在评价LBL-034在多种复发/难治的浆细胞肿瘤患者中的疗效和安全性。
LBL-034是一款全球独创2:1结构设计的GPRC5D/CD3双特异性抗体，通过优化抗CD3亲和力和空间位阻作用，显著降低了对T细胞的非特异性激活的风险，同时保持高效的T细胞条件激活能力，从而兼具强大抗肿瘤活性和更佳安全性，具备同类最佳潜力。
在此前开展的Ⅰ期临床研究中，50余例入组患者在80-1200μg/kg剂量下均显示出良好的安全性和有效性，尤其在高剂量中表现出类似于CAR-T的疗效，且未带来额外安全性风险。值得关注的是，伴髓外瘤患者同样表现出显著疗效和良好安全性，微小残留病灶（MRD）阴性率也明显高于目前标准治疗。
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