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Legend Biotech to Launch CAR T-Cell Therapy Trial for Small Cell Lung Cancer, Neuroendocrine Tumors

NEW YORK – Legend Biotech said on Monday that it will begin evaluating its autologous CAR T-cell therapy LB2102 in a Phase I trial as a treatment for patients with small cell lung cancer and certain neuroendocrine tumors.

The US Food and Drug Administration has cleared Legend's investigational new drug application for the therapy, allowing the firm to launch its first-in-human clinical trial evaluating LB2102 for patients with extensive stage SCLC and large-cell neuroendocrine carcinoma.

The primary aims of the trial include evaluating the treatment's safety and preliminary efficacy as well as determining its recommended Phase II dose.

The autologous CAR T-cell therapy is designed to target the delta-like ligand 3 (DLL-3), which is expressed on SCLC as well as LCNEC, other neuroendocrine tumors, and some prostate cancers.