NK Cell Therapy for Malignant Solid Brain Tumors
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.
Timeline
- Start
- 2026-04
- Primary completion
- 2030-12
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | autologous NK cells | Cell therapy | 1e+08 cells | Intrathecal |
| Subject | autologous NK cells | Cell therapy | 2e+08 cells | Intrathecal |
| Subject | autologous NK cells | Cell therapy | 9e+08 cells | Intrathecal |
| Subject | autologous NK cells | Cell therapy | 2.9e+09 cells | Intrathecal |