Injection of natural killer cells for treating 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
This study is testing whether a new treatment using natural killer cells can help young patients with high-grade gliomas, like glioblastoma, fight their cancer better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 3 Years to 70 Years |
| Sex | All |
| Sponsor | Kian Immune Cell Company Industry-sponsored |
| Drugs / interventions | Immunotherapy, radiation |
| Locations | 1 site (Tehran) |
| Trial ID | NCT06687681 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of active allogeneic natural killer (NK) cells as a treatment for patients diagnosed with high-grade gliomas, including glioblastoma. The study focuses on patients aged 3 to 60 years who meet specific health criteria and have not previously undergone treatment for their tumors. Participants will receive NK cell therapy, which aims to enhance the immune response against cancer cells. The trial seeks to evaluate the safety and efficacy of this immunotherapy approach in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include newly diagnosed patients aged 3 to 60 with grade 3 or 4 gliomas, such as glioblastoma or other specified high-grade tumors.
Not a fit: Patients with evidence of radio necrosis, other malignancies, or significant uncontrolled chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel immunotherapy option that may improve survival rates for patients with high-grade gliomas.
How similar studies have performed: Other studies have shown promise in using immunotherapy approaches like NK cell therapy for various cancers, indicating potential success for this novel application in gliomas.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \-
Where this trial is running
Tehran
- Rasoul Akram hospital — Tehran, Iran (Recruiting)
Study contacts
- Study coordinator: Marzieh Ebrahimi, PhD
- Email: mebrahimi@royan-rc.ac.ir
- Phone: +98 21 235 62516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.