Efficacy of allogenic NK cells IT injection in patients with high grade brain glioma

Phase 2

Recruiting

• Conditions: High grade brain glioma.; Malignant neoplasm of brain

• Registration Number: IRCT20170122032121N7
• Lead Sponsor: Kian immune cell company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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, IDH-mutant • 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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate comparison between control and intervention groups. Timepoint: 1 to 2 weeks after last injection with the follow up of 3, 6, and 12 months after last injection. Method of measurement: Using iRANO (Immunotherapy Response Assessment in Neuro-Oncology) checklist and using MRI and MRS.

Secondary Outcome Measures

Name	Time	Method
Safety. Timepoint: After each injection to next injection and 2 weeks after last injection. Method of measurement: Using CTCAEs (Common Terminology Criteria for Adverse Events) checklist.;Overall survival and progression-free survival. Timepoint: After the end of the study. Method of measurement: using Kaplan-Meier method.;Analysis of CSF including: hematology, biochemistry, culture, cytokine level and immunophenotype of cells. Timepoint: Before each injection, CSF sample will be taken from patients for analysis. Method of measurement: using microscope and slides, spectrophotometer, enzyme assay, ELISA and Flowcytometry.