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NK Cell Therapy for Malignant Solid Brain Tumors
Sponsor: Peking University Third Hospital
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
Conditions
Interventions
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