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

NCT07274449 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

  • Advanced Solid Cancers

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.

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-08
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07274449 on ClinicalTrials.gov