Efficacy of Intrathecal Injection of Active Allogeneic Natural Killer Cells in High-grade Gliomas A Multi-center Phase II Clinical Trial

What this Trial Is About

Gliomas are the most common malignant brain tumors often linked to high-grade tumors with poor prognosis and low survival rates in both children and adults. Standard treatments include surgical tumor removal and whole-brain radiation therapy, which has limited benefit and significant side effects. Targeted therapies have shown some tumor shrinkage but usually followed by recurrence. Immunotherapy using natural killer (NK) cells is a newer approach being studied to better identify and destroy cancer cells, especially when traditional treatments have limited success. This phase II clinical trial evaluates the use of active allogeneic NK cell injections delivered through lumbar puncture into the spinal fluid. Patients with newly diagnosed grade 3 or 4 gliomas, including several specific tumor types, will be randomly assigned to receive either three courses of intrathecal NK cell infusions every three weeks in addition to conventional treatment or conventional treatment alone. The study spans multiple centers and focuses on patients aged 3 to 60 years with adequate blood counts and organ function. Participants will undergo monitoring for tumor response over a 12-month period following treatment. Safety and adverse events will be tracked for one month after enrollment. The study involves regular clinical assessments, blood tests, and imaging to evaluate the tumor and overall health. Consent is obtained from patients or guardians for children, and performance status is assessed to ensure suitability for participation. Researchers aim to measure how well the tumor responds to NK cell therapy and evaluate any treatment-related side effects.

Injection of Active Allogeneic Natural Killer Cells in Patients With Gliomas