Nanjing Leads Biolabs Co., Ltd, a China-based biopharmaceutical company, has announced receiving clinical trial approvals from both the National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb), LBL-034. The drug targets GPRC5D and CD3 and is intended to treat recurrent/refractory (r/r) multiple myeloma (MM), a disease for which no GPRC5D-targeted antibody drugs have been approved globally.
Study Design and Objectives
The upcoming clinical trial is a single-arm, multi-center, open-label study that includes both dosage escalation and expansion phases. It is designed to assess the safety and tolerability of LBL-034 in patients with r/r MM who have previously received at least one proteasome inhibitor (PI), one immunomodulator (IMiD), and other standard treatments that have failed. The study aims to determine the Phase II recommended dosage and evaluate the efficacy of LBL-034.
LBL-034’s Mechanism of Action
LBL-034 is a humanized IgG1 subtype asymmetric BsAb that targets both GPRC5D and CD3 simultaneously. It has the potential to induce T cell-mediated cytotoxicity against myeloma cells by bridging CD3+ T cells and GPRC5D-expressing myeloma cells. GPRC5D is a receptor that is lowly expressed in normal human tissues but is specifically overexpressed in malignant plasma cells of MM patients, making it an attractive target for novel therapies.-Fineline Info & Tech
