Injection of Active Allogeneic Natural Killer Cells in Patients With Gliomas

NCT06687681 | Recruiting Phase 2 DMC

• 1 other identifier: IR.ACECR.ROYAN.REC.1402.001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma Glioblastoma Multiforme; High Grade Glioma (III or IV)

Keywords

natural killer cells; Brain glioma; NK cells; glioblastoma; high grade gliomas

Outcome Measures

Primary Outcomes (1)

• To measure tumor response after infusion of intrathecal NK cells

  Imaging and Immunotherapy Response Assessment in Neuro-oncology (iRANO) guidelines

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (1)

• Adverse Events (AEs)

  From enrollment to the end of treatment at one months

Study Arms (2)

Test group

EXPERIMENTAL

patients will recieve 3 cources of 2\* 10 8 intrathecal infusion of NK cells every 3 weeks

Biological: NK cell therapy

Control group

NO INTERVENTION

patients will recieve only conventional treatment

Interventions

NK cell therapy BIOLOGICAL

Active NK cell injection through lumbar puncture in patient with Astrocytoma IDH-mutant, Oligodendroglioma IDHmutant, Glioblastoma IDH-wild type, Diffuse midline glioma, Diffuse hemispheric glioma, Diffuse pediatrictype high-grade glioma IDH-wild type

Test group

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Marzieh Ebrahimi: lead

Study Sites (1)

Rasoul Akram hospital

Tehran, 1343864331, Iran

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Marzieh Ebrahimi, PhD

CONTACT

+98 21 235 62516; mebrahimi@royan-rc.ac.ir

Mohammad Faranoush, MD

CONTACT

+98 9121590517

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medical Immunology

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: November 25, 2024
• Primary Completion: November 25, 2025
• Study Completion (Estimated): November 25, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)