肿瘤细胞治疗研究
英文原题：Clinical Pharmacology Profile of AMG 119, the First Chimeric Antigen Receptor T (CAR-T) Cell Therapy Targeting Delta-Like Ligand 3 (DLL3), in Patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC).
凭借可能单次给药即可治愈的方案前景，CAR-T 细胞治疗为血液系统恶性肿瘤的治疗和管理带来了范式转变，美国已有 6 款获批产品。
AMG 119是一种靶向δ样配体3（DLL3）的CAR-T 细胞疗法，曾作为复发或难治性小细胞肺癌（SCLC）的首个DLL3 CAR-T候选疗法进行临床开发。本研究描述其临床药理学特征，评估CAR-T细胞扩增和持续时间与药物暴露及临床结局之间的关系。研究结果显示，在所评估剂量下，AMG 119总体安全且耐受性良好，未观察到剂量限制性毒性；其体内扩增和持续情况呈现可分析的暴露-反应关系。该临床药理学分析为理解DLL3靶向CAR-T在SCLC中的表现提供了依据。
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 AMG 119, the first CAR-T cell therapy targeting delta-like ligand 3 (DLL3), in patients with relapsed/refractory (R/R) small cell lung cancer (SCLC). AMG 119 demonstrated robust cellular expansion with long-lasting cell persistence and a favorable exposure-response relationship. AMG 119 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.
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