RecruitingNot ApplicableNCT07552233

NK Cell Therapy for Malignant Solid Brain Tumors

NK Cell Therapy for the Treatment of Malignant Solid Brain Tumors


Sponsor

Peking University Third Hospital

Enrollment

27 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Autologous NK cells for people with brain metastasis, glioblastoma (gbm), and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAutologous 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

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NCT07552233


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