Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma Glioblastoma Multiforme | — | UNRESOLVED | — |
| High Grade Glioma (III or IV) | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NK cell therapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test group
- description
- patients will recieve 3 cources of 2\* 10 8 intrathecal infusion of NK cells every 3 weeks
- interventionNames
- Biological: NK cell therapy
- type
- NO_INTERVENTION
- label
- Control group
- description
- patients will recieve only conventional treatment
Primary outcomes (1)
- measure
- To measure tumor response after infusion of intrathecal NK cells
- timeFrame
- From enrollment to the end of treatment at 12 months
- description
- Imaging and Immunotherapy Response Assessment in Neuro-oncology (iRANO) guidelines
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 \-
References
Publications (0)
Data not yet available