NK Cell Therapy for Malignant Solid Brain Tumors
ClinicalTrials.gov Studies
Summary
A multi-center, open-label investigator-initiated trial (IIT) registered on ClinicalTrials.gov evaluating 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 immunological effects.
“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.”
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What changed
This document adds a new clinical trial registration (NCT07552233) to ClinicalTrials.gov for an investigator-initiated study of autologous NK cell therapy for malignant solid brain tumors. The trial will enroll adult patients with glioblastoma, glioblastoma multiforme, brain metastasis, or malignant meningioma who have failed standard treatment.
Healthcare providers and clinical investigators involved in neuro-oncology or immunotherapy research may encounter this trial as a reference point for patient referrals or competitive landscape awareness. The trial's dose-escalation design and RANO-criteria endpoints may inform similar study designs for cell-based cancer therapies.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
NK Cell Therapy for Malignant Solid Brain Tumors
N/A NCT07552233 Kind: NA Apr 27, 2026
Abstract
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.
Conditions: Malignant Solid Brain Tumors, Glioblastoma (GBM), Glioblastoma Multiforme (GBM), Brain Metastasis, Malignant Meningioma
Interventions: Autologous NK cells
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