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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Gliomas are the most common malignant brain tumors, which are often associated with high-grade tumors characterized by an inferior prognosis and low patient survival rates in both children and adults. Surgical removal and tumor resection are the primary treatment approaches for gliomas. In such cases, whole-brain radiation therapy is also employed as a therapeutic option, which itself has significant side effects, and studies have shown limited impact on improving patient survival. Targeted therapy and recently investigated approaches such as targeted therapy have shown some tumor regression, but in most cases, tumor recurrence has been observed after initial regression. Therefore, they have a limited impact on prolonging patient survival. Immunotherapy, particularly immunotherapy with specific immune cells, can effectively identify and eliminate cancer cells and has been utilized as a new approach in the past two decades, especially in cancers where conventional methods have limited success. Among the effective immunotherapy methods, using natural killer cells (NK cells) can be one of the promising approaches. Currently, phase I clinical trials have been conducted by our research group in patients with gliomas.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 70
Healthy Volunteers: f
View:
Locations
Other Locations
Islamic Republic of Iran
Rasoul Akram hospital
RECRUITING
Tehran
Contact Information
Primary
Marzieh Ebrahimi, PhD
mebrahimi@royan-rc.ac.ir
+98 21 235 62516
Backup
Mohammad Faranoush, MD
+98 9121590517
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2027-11-25
Participants
Target number of participants: 40
Treatments
Experimental: Test group
patients will recieve 3 cources of 2\* 10 8 intrathecal infusion of NK cells every 3 weeks
No_intervention: Control group
patients will recieve only conventional treatment
Sponsors
Leads: Marzieh Ebrahimi

This content was sourced from clinicaltrials.gov