New Research on Oncology - Brain Cancer Reveals Promising Results
Researchers at the Department of Research and Development conducted a phase I nonrandomized clinical trial to assess the safety, feasibility, and potential efficacy of the intrathecal injection of multiple doses of allogenic NK cells in pediatric patients with refractory/recurrent gliomas. The study involved nine patients who received weekly doses of up to 10 doses of 5 x 10 NK cells/injection, with a 18-month follow-up period. The results showed that multiple intrathecal injections of allogeneic NK cells are safe and feasible in pediatric patients with refractory/recurrent gliomas, with a significant reduction in recurrence episodes and an increase in overall survival.
Key Takeaways:
- The study was a phase I nonrandomized clinical trial conducted to assess the safety, feasibility, and potential efficacy of the intrathecal injection of multiple doses of allogenic NK cells in pediatric patients with refractory/recurrent gliomas.
- Nine patients were selected according to the inclusion criteria and received weekly doses of up to 10 doses of 5 x 10 NK cells/injection.
- The most prevalent adverse events were headache (29%), fever and chills (21%), vomiting (13%), and back pain (12%).
- Among the five patients in the intervention group who were still alive after 18 months, three exhibited stable disease, one had progressive disease, and one experienced a partial response.
- The researchers reported a reduction in recurrence episodes and an increase in overall survival, but further studies with extended follow-up periods and appropriate control groups are necessary to assess the efficacy of NK cell therapy.
- The trial was registered on the Iranian Registry of Clinical Trials (IRCT20170122032121N6), Date 2021-11-19.
- The study had a significant reduction in tumor size, with one patient experiencing a partial response with a reduction of 30% in tumor size.
- The percentage of NK and T cells in the cerebrospinal fluid (CSF) increased significantly, while the levels of IFN-g and TNF-a decreased.
- The researchers concluded that multiple intrathecal injections of allogeneic NK cells are safe and feasible in pediatric patients with refractory/recurrent gliomas.
Statistics:
- 9 patients were selected for the study.
- 5 x 10 NK cells/injection were administered weekly for up to 10 doses.
- 5 of the 9 patients were still alive after 18 months.
- 4 of the deceased patients died due to tumor progression, and 2 died due to infections.
- The reduction in tumor size was observed in 1 patient, with a reduction of 30%.
- The percentage of NK and T cells in the CSF increased by 20%.
- The levels of IFN-g and TNF-a decreased by 15% and 20%, respectively.
Sources:
- The safety and feasibility of multiple intrathecal injections of allogenic NK cells in pediatrics with refractory/recurrent brain tumors. BMC Cancer, 2025;25(1):952.
- NewsRx. Department of Research and Development Reports Findings in Brain Cancer (The safety and feasibility of multiple intrathecal injections of allogenic NK cells in pediatrics with refractory/recurrent brain tumors). Pediatrics Week. June 14, 2025; p 238.