This study is a single-center, prospective, Phase Ib/II clinical trial designed to evaluate the safety and efficacy of cell membrane-modified memory NK cells in treating patients with advanced metastatic solid tumors.
The primary objective of this study is to evaluate the safety and tolerability profile of memory NK cells administered in combination with standard therapy in the Intent-to-Treat (ITT) population. The assessment will be based on the following endpoints: 1）Incidence of dose-limiting toxicities (DLTs)； 2) Frequency and severity of adverse events; 3) Occurrence of clinically significant abnormalities in laboratory parameters, physical examinations, and vital signs.
The secondary Study Objectives: 1) To evaluate the preliminary efficacy of the combination regimen by assessing the objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and serial changes in tumor markers; 2) To characterize the pharmacokinetic profile of memory NK cells when used in combination with standard therapy within the ITT population.
A pilot cohort of 6 patients will first be enrolled to assess the safety of NK cell therapy, with dose-limiting toxicities (DLT) evaluated over a 21-day observation period following the last NK cell infusion. If safety is confirmed, a protocol amendment for cohort expansion will be submitted to the Ethics Committee.