Legend Biotech Corporation announced that the U.S. Food and Drug Administration has cleared its investigational new drug application to evaluate LB1908 in a Phase 1 clinical trial in the United States. LB1908 is an investigational, autologous chimeric antigen receptor T-cell therapy selectively targeting Claudin 18.2 through a high-affinity VHH antibody for the treatment of adults with relapsed or refractory gastric, esophageal or pancreatic cancers. Claudin18.2 is a tight junction protein commonly expressed in patients with these cancer subtypes.

The Phase 1, first-in-human, open-label, multicenter clinical study seeks to characterize the safety and tolerability of LB1908, as well as determine the recommended dose for Phase 2 and evaluate preliminary efficacy. Study will have dose escalation and dose expansion phases. Patients enrolled in the study must sufficiently express Claudin 18.2. A Phase 1 investigator-initiated trial evaluating LB1908 for advanced gastric cancers is also ongoing in China.