T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma

Sponsor
Queensland Institute of Medical Research
Study ID
NCT06157541
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Astrocytoma, Grade IV
  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic cytomegalovirus-specific T cells — BIOLOGICAL
    Allogeneic cytomegalovirus (CMV)-specific T cells generated from the blood of healthy CMV-seropositive donors
  • Pembrolizumab — DRUG
    A humanised immunoglobulin G4 (IgG4) monoclonal antibody (mAb) specific for the programmed cell death 1 (PD-1) receptor

Study Details

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.

Key Dates

Start date
Feb 8, 2024
Status verified
May 2024
Primary completion
Apr 30, 2026
Completion
Jan 31, 2028

Study Design

Enrollment
58 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    Patients with recurrent disease. Interventions: * allogeneic CMV-specific T cells (cell suspension for infusion), dose cohorts: 2 × 10\^7 cells, 4 × 10\^7 cells, 8 × 10\^7 cells; 4 infusions; administered weekly * pembrolizumab 400 mg (solution for injection); 18 infusions; administered every 6 weeks
  • Experimental: Part 2 Group A
    Patients with recurrent disease. Interventions: * allogeneic CMV-specific T cells (cell suspension for infusion), maximum-tolerated dose identified in phase I; 4 infusions; administered weekly * pembrolizumab 400 mg (solution for injection); 18 infusions; administered every 6 weeks
  • Experimental: Part 2 Group B
    Patients with newly diagnosed disease. Interventions: * allogeneic CMV-specific T cells (cell suspension for infusion), maximum-tolerated dose identified in phase I; 4 infusions; administered weekly * pembrolizumab 400 mg (solution for injection); 18 infusions; administered every 6 weeks

Primary Outcome Measure

Incidence of dose-limiting toxicities [ Time Frame: Within 49 days of receiving the first dose of study drug ]

Central Contacts

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