RecruitingPhase 2NCT06687681

Injection of Active Allogeneic Natural Killer Cells in Patients With Gliomas

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


Sponsor

Marzieh Ebrahimi

Enrollment

40 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 3 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether injecting natural killer (NK) immune cells from a donor directly into patients with newly diagnosed high-grade brain tumors (gliomas) can help fight the cancer. **You may be eligible if...** - You have been newly diagnosed with a grade 3 or 4 brain tumor (such as glioblastoma, astrocytoma, oligodendroglioma, or diffuse high-grade glioma) - You are between 3 and 60 years old - Your general performance level is above a certain minimum (Lansky/Karnofsky score above 60) - Your blood counts and organ function (liver, kidney, platelets) are within acceptable levels **You may NOT be eligible if...** - There is evidence of radiation-related tissue damage (radionecrosis) on your MRI - You have a history of another cancer - You have an immune deficiency or compromised immune system - You are pregnant - You have uncontrolled chronic diseases such as diabetes, heart failure, cirrhosis, or chronic kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNK 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


Locations(1)

Rasoul Akram hospital

Tehran, Iran

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NCT06687681


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