Actively Recruiting

Phase 2
Age: 3Years - 70Years
All Genders
NCT06687681

Injection of Active Allogeneic Natural Killer Cells in Patients With Gliomas

Led by Marzieh Ebrahimi · Updated on 2025-04-09

40

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Injection of Active Allogeneic Natural Killer Cells in Patients With Gliomas

Who Can Participate

Age: 3Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed patients with grade 3 or 4 brain tumor based on WHO classification, including Astrocytoma IDH-mutant, Oligodendroglioma IDH-mutant, Glioblastoma IDH-wild type, Diffuse midline glioma, Diffuse hemispheric glioma, or Diffuse pediatric-type high-grade glioma IDH-wild type
  • Age between 3 and 60 years old, any sex
  • Lansky/Karnofsky performance score above 60
  • Informed consent obtained from patient or parent/legal guardian for pediatric patients
  • Hemoglobin above 10 g/dL
  • Absolute granulocyte count above 500 per microliter of blood
  • Platelet count above 50,000 per microliter of blood
  • INR below 2 and PTT less than 1.5 times the maximum normal value
  • Plasma bilirubin level less than 1.5 times the maximum normal value
  • Plasma hepatic transaminases (ALT and AST) levels less than 3 times the maximum normal value
  • Plasma creatinine level less than 1.5 times the maximum normal value
Not Eligible

You will not qualify if you...

  • Evidence of radioactive necrosis on MRI or MRS
  • Intolerance to new treatment due to emergency condition
  • History of other malignancies
  • History of immunodeficiency diseases or immune compromising conditions
  • Rupture of cerebral shunt or inability to perform lumbar puncture
  • Pregnancy
  • History of uncontrolled chronic diseases such as diabetes, congestive heart failure, liver cirrhosis, chronic kidney disease, etc.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rasoul Akram hospital

Tehran, Iran, 1343864331

Actively Recruiting

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Research Team

M

Marzieh Ebrahimi, PhD

CONTACT

M

Mohammad Faranoush, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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