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ACTIVE NOT RECRUITING
NCT07274449
PHASE1/PHASE2

Exploratory Clinical Study on Memory NK Cell Therapy for Advanced Metastatic Solid Tumors

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2025-05-08

Completion Date

2028-12-31

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

Memory-Like NK Cells

The study employs iRGD-modified cytokine-induced memory-like NK cells. These memory NK cells-primed with IL-12, IL-15, and IL-18-exhibit enhanced antitumor functionality, characterized by ↓KIR expression, ↑NKP30 expression, increased IFN-γ/TNF-α secretion, and significantly improved in vitro cytotoxicity. The iRGD modification, applied to cell membranes using our proprietary tumor-penetrating peptide technology, confers active tumor-targeting and tissue-penetrating capabilities to the NK cells.

Locations (1)

Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

Nanjing, Jiangsu, China