NK Cell Therapy for Malignant Solid Brain Tumors

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.

NCT Number	NCT07552233
Lead Sponsor	Peking University Third Hospital Collaborators: Henan Academy of Innovations in Medical Science, Zhengzhou Second Hospital, Qinhuangdao Runze Hospital
Conditions	Malignant Solid Brain Tumors, Glioblastoma (GBM), Glioblastoma Multiforme (GBM), Brain Metastasis, Malignant Meningioma
Enrollment	27 participants
Start Date	2026-04
Primary Completion	2030-12 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-27