Clinical Pharmacology Profile of AMG119, the First Chimeric Antigen ReceptorT (CAR-T) Cell Therapy Targeting Delta-Like Ligand3 (DLL3), in Patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC).

Abstract

With the promise of a potentially single-dose curative regimen, CAR-T cell therapies have brought a paradigm shift in the treatment and management of hematological malignancies with 6 approved products in the USA. However, there are no approved CAR-T cell therapies for solid tumors. Herein, we report the clinical pharmacology profile of AMG119, the first CAR-T cell therapy targeting delta-like ligand3 (DLL3), in patients with relapsed/refractory (R/R) small cell lung cancer (SCLC). AMG119 demonstrated robust cellular expansion with long-lasting cell persistence and a favorable exposure-response relationship. AMG119 has been demonstrated to be clinically safe and well tolerated at the doses tested, with no dose-limiting toxicities (DLTs) reported. This is the first publication of the clinical pharmacology profile of a CAR-T cell therapy in SCLC, with encouraging cellular kinetics data supporting the potential for CAR-T cell therapy in solid tumor space.