The US Food and Drug Administration and National Medical Products Administration have approved the Investigational New Drug (IND) applications for LBL-034, an anti-GPRC5D/CD3 bispecific antibody, for the treatment of relapsed or refractory multiple myeloma.
A first-in-human, single-arm, dose-escalation and expansion clinical trial will enroll patients with relapsed or refractory multiple myeloma who experienced failure of prior therapies, including at least one proteasome inhibitor, one immunomodulator, and other standard treatments, according to Leads Biolabs, the manufacturer of the drug.
The company said the multicenter, open-label study will evaluate the safety and tolerability of LBL-034, determine the recommended phase II dose, and assess the efficacy of LBL-034 in patients with multiple myeloma.
Source: PR Newswire, July 2023
