On August 25, LEADS BIOLABS-B (09887) announced that the company's independently developed GPRC5D/CD3 bispecific antibody has successfully completed enrollment of the first patient in its Phase II clinical study (CTR20232974), potentially becoming the first domestic TCE therapy targeting GPRC5D.

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

LBL-034 is a globally innovative GPRC5D/CD3 bispecific antibody with a unique 2:1 structural design. Through optimized anti-CD3 affinity and spatial steric effects, it significantly reduces the risk of non-specific T-cell activation while maintaining highly efficient conditional T-cell activation capability, thereby combining potent anti-tumor activity with enhanced safety profile and best-in-class potential.

In the previously conducted Phase I clinical study, over 50 enrolled patients demonstrated favorable safety and efficacy across the 80-1200μg/kg dose range. Particularly at higher doses, the treatment showed CAR-T-like efficacy without introducing additional safety risks. Notably, patients with extramedullary tumors also exhibited significant efficacy and good safety profile, with minimal residual disease (MRD) negative rates significantly higher than current standard treatments.