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RECRUITING
NCT07552233
NA

NK Cell Therapy for Malignant Solid Brain Tumors

Sponsor: Peking University Third Hospital

View on ClinicalTrials.gov

Summary

This is a multi-center, open-label investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, and feasibility of combined intracranial and intravenous administration of ex vivo expanded and activated natural killer (NK) cells in adult patients with malignant solid brain tumors who have failed standard treatment modalities. The primary objective is to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of the combined NK cell therapy. Secondary objectives include preliminary assessment of anti-tumor activity as measured by progression-free survival (PFS), overall survival (OS), objective response rate (ORR) per RANO criteria, and evaluation of the immunological effects of NK cell infusion in the tumor microenvironment and peripheral blood.

Official title: NK Cell Therapy for the Treatment of Malignant Solid Brain Tumors

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2026-04

Completion Date

2030-12-31

Last Updated

2026-04-27

Healthy Volunteers

No

Interventions

DRUG

Autologous NK cells

Intrathecal Administration Combined with Intravenous Infusion of Autologous NK Cells 1. Intracranial/Intrathecal Injection: NK cells are administered into the cerebrospinal fluid via a surgically implanted intracranial Ommaya reservoir or lumbar puncture. This approach successfully bypasses the blood-brain barrier, allowing NK cells to act directly on tumor lesions in the central nervous system. 2. Intravenous Infusion: Following intracranial/intrathecal injection, the patient receives an intravenous infusion of NK cells.

Locations (4)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Qinhuangdao Runze Hospital

Qinhuangdao, Hebei, China

Zhengzhou Second Hospital

Zhengzhou, Henan, China

Henan Academy of Innovations in Medical Science

Zhengzhou, Henan, China