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T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma

NCT06157541 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-05-31

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Allogeneic cytomegalovirus-specific T cells

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

DRUG

Pembrolizumab

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

Sponsors & Collaborators

  • CUREator

    collaborator UNKNOWN

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • The Newro Foundation

    collaborator UNKNOWN

  • Royal Brisbane and Women's Hospital

    collaborator OTHER_GOV

  • Princess Alexandra Hospital, Brisbane, Australia

    collaborator OTHER

  • Austin Hospital, Melbourne Australia

    collaborator OTHER

  • Queensland Institute of Medical Research

    lead OTHER

Principal Investigators

  • Rajiv Khanna, PhD · QIMR Berghofer Medical Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-08
Primary Completion
2026-04-30
Completion
2028-01-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06157541 on ClinicalTrials.gov