RecruitingPhase 1Phase 2NCT06157541

T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma

Phase I/II Clinical Trial of Allogeneic Cytomegalovirus-specific T Cells in Combination With Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma Multiforme


Sponsor

Queensland Institute of Medical Research

Enrollment

58 participants

Start Date

Feb 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test a combined therapy approach (allogeneic cytomegalovirus \[CMV\]-specific T cells and pembrolizumab) in patients with brain cancer. The type of brain cancer being studied is glioblastoma multiforme/astrocytoma grade 4. The purpose of part 1 of this study is to determine the maximum-tolerated dose and/or recommended dose(s) for future exploration of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab in patients with recurrent GBM/astrocytoma grade 4. Part 2 of the study aims to investigate the anti-tumour activity of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab, assessed by magnetic resonance imaging and survival, in patients with recurrent or newly diagnosed GBM/grade 4 astrocytoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of personalized immune cells (called T cells) engineered to fight brain tumors, together with the immunotherapy drug pembrolizumab, in patients with glioblastoma — one of the most aggressive forms of brain cancer — both newly diagnosed and recurrent cases. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with glioblastoma (grade 4 brain tumor) confirmed by biopsy - Your diagnosis may be a new diagnosis or a recurrence - You meet the general health and organ function requirements **You may NOT be eligible if...** - You are under 18 years old - You have not had a confirmed tissue diagnosis of glioblastoma - You have conditions that make immunotherapy unsafe - Your health status or organ function does not meet the study requirements 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAllogeneic cytomegalovirus-specific T cells

Allogeneic cytomegalovirus (CMV)-specific T cells generated from the blood of healthy CMV-seropositive donors

DRUGPembrolizumab

A humanised immunoglobulin G4 (IgG4) monoclonal antibody (mAb) specific for the programmed cell death 1 (PD-1) receptor


Locations(4)

Newro Foundation

Bowen Hills, Queensland, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Austin Hospital

Heidelberg, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06157541


Related Trials