Nanjing Leads Biolabs Co., Ltd.  announced the first patient has been successfully dosed in the Phase Ⅱ trial of LBL-034 (GPRC5D/CD3 BsAb) following strong Phase Ⅰ data. This milestone endows LBL-034 with the potential to become the first domestic T-cell engager (TCE) therapy targeting GPRC5D.

Innovative Design with Best-in-Class Potential

LBL-034 is a GPRC5D/CD3 bispecific T-cell engager with a uniquely designed 2:1 format. By optimizing anti-CD3 affinity and steric hindrance, LBL-034 effectively redirects and activates T cells to target GPRC5D+ cancer cells, being less prone to inducing nonspecific T-cell activation. This dual advantage—robust antitumor efficacy combined with favorable safety—positions LBL-034 as a best-in-class candidate.

Outstanding Phase Ⅰ Data with Initial Evidence of CAR-T-Like Efficacy

LBL-034 has demonstrated strong efficacy signal and favorable safety profile among over 50 enrolled patients at dose levels up to 1200 μg/kg in its open-label, multi-center, dose-escalation/expansion phase Ⅰ trial for the treatment of relapsed/refractory multiple myeloma (MM). At higher doses, LBL-034 showed a robust objective response rate (ORR) similar to CAR-T treatment. Notably, promising efficacy was also observed in the subgroup of patients with difficult-to-treat extramedullary (EMD) plasmacytomas. Furthermore, the minimal residual disease (MRD) negativity rate was also significantly higher than with current standard of care. The detailed results of this study, including efficacy, safety, PK/PD, biomarker, and exposure-response analyses, will be presented at the 2025 American Society of Hematology Annual Meeting.

Phase Ⅱ Trial Initiated

The Phase Ⅱ trial of LBL-034 is a multi-center, single-arm, multi-cohort clinical trial led by Professor Lu Jin of Peking University People's Hospital, with participation from over 20 hospitals across China. The trial aims to evaluate the efficacy and safety of LBL-034 in patients with various relapsed/refractory plasma cell neoplasms.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "The successful dosing of the first Phase Ⅱ patient marks a critical step in our TCE pipeline and validates our unique molecular design. We will continue advancing clinical development with high standards to deliver China's first GPRC5D-targeted TCE therapy, offering patients safer and more effective options."

Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs, added, "LBL-034's exceptional Phase Ⅰ data and smooth Phase Ⅱ initiation underscore the core advantage of our Leadsbody™ platform—conditional activation. This success bolsters confidence in our broader pipeline and accelerates breakthroughs in TCE therapies for solid tumors, hematologic malignancies, and autoimmune diseases. We remain committed to driving innovation and delivering transformative treatments globally."