Injection of Active Allogeneic Natural Killer Cells in Patients With Gliomas

NCT ID: NCT06687681

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2027-11-25

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.

Detailed Description

Inclusion criteria:

New diagnosed patients with grade 3 or 4 brain tumor, based on WHO classification, which are included in the one of the following conditions: • Astrocytoma, IDHmutant • Oligodendroglioma, IDH-mutant • Glioblastoma, IDH-wild type • Diffuse midline glioma • Diffuse hemispheric glioma • Diffuse pediatric-type high-grade glioma, IDH-wild type Age range of 3 to 60 years old both sex Lansky/Karnofsky performance score above 60 Obtained informed consent of patients or parents or legal attendance in cases of pediatrics Hemoglobin above 10 gr/dL of blood Absolute granulocyte count (AGC) above 500 per microliter of blood Platelet count above 50000 per microliter of blood INR below 2 and PTT less than 1.5 times of maximum normal value Plasma bilirubin level less than 1.5 times of maximum normal value Plasma hepatic transaminases (ALT and AST) level less than 3 times of maximum normal value Plasma creatinine level less than 1.5 times of maximum normal value

Exclusion criteria:

Evidence of radio necrosis in MRI or MRS Intolerance of new treatment due to emergency condition History of other malignancies History of any immunodeficiency diseases or any immune compromising conditions Rupture of cerebral shunt or unable to perform a lumbar puncture Pregnancy History of uncontrolled chronic diseases such as: Diabetes, CHF, liver cirrhosis, CKD, etc

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test group

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

Group Type: EXPERIMENTAL

NK cell therapy

Intervention Type: 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

Control group

patients will recieve only conventional treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NK cell therapy

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marzieh Ebrahimi

INDUSTRY

Sponsor Role: lead

Responsible Party

Marzieh Ebrahimi

Professor of Medical Immunology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Rasoul Akram hospital

Tehran, , Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Marzieh Ebrahimi, PhD

Role: CONTACT

mebrahimi@royan-rc.ac.ir

+98 21 235 62516

Mohammad Faranoush, MD

Role: CONTACT

+98 9121590517

Facility Contacts

Mohammad Faranoush, MD

Role: primary

faranoush.m@iums.ac.ir

+98 9121590517

Other Identifiers

IR.ACECR.ROYAN.REC.1402.001

Identifier Type: -

Identifier Source: org_study_id