Injection of Active Allogeneic Natural Killer Cells in Patients With Gliomas

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-70
SponsorMarzieh Ebrahimi

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • NK cell therapy

    Biological/Vaccine

    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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Test groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

To measure tumor response after infusion of intrathecal NK cells

Imaging and Immunotherapy Response Assessment in Neuro-oncology (iRANO) guidelines

Time frame
From enrollment to the end of treatment at 12 months

Secondary outcomes

1

Adverse Events (AEs)

Using CTCAEs (Common Terminology Criteria for Adverse Events) checklist

Time frame
From enrollment to the end of treatment at one months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marzieh Ebrahimi

Lead sponsor

Kian Immune Cell Company

Sponsor institution