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Allogeneic cytomegalovirus-specific T cells · 1 trial · 2 indications
Part 1 - Primary Endpoint 1
Part 1 - Primary Endpoint 2
Part 2 - Primary Endpoint 1
Part 2 - Primary Endpoint 2
Part 2 - Primary Endpoint 3
Part 2 - Primary Endpoint 4
Part 2 - Primary Endpoint 5
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | 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 |
| Part 2 Group A | EXPERIMENTAL | 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 |
| Part 2 Group B | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: 1. At least 18 years of age on the day of signing informed consent, with histologically confirmed diagnosis of GBM or astrocytoma Grade 4\^. a. For participants with recurrent GBM or astrocytoma grade 4, histological confirmation of primary diagnosis is available i. First oc...
Allogeneic cytomegalovirus-specific T cells are being studied as a treatment for Glioblastoma Multiforme, including recurrent and newly diagnosed cases. The therapy is in Phase 1 clinical development and is being evaluated in combination with pembrolizumab in a controlled trial.
Allogeneic cytomegalovirus-specific T cells are being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting a Phase 1 clinical trial to evaluate the therapy in patients with Glioblastoma Multiforme.
Allogeneic cytomegalovirus-specific T cells are in Phase 1 clinical development. The therapy is investigational and is being studied in an active, not recruiting clinical trial for Glioblastoma Multiforme, including recurrent and newly diagnosed cases.
Allogeneic cytomegalovirus-specific T cells are being studied in clinical trial NCT06157541, titled "T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma." This Phase 1 trial is active but not recruiting, with an enrollment of 58 participants in Australia.
Allogeneic cytomegalovirus-specific T cells are classified as a monoclonal antibody modality. The therapy is being evaluated in a Phase 1 trial for Glioblastoma Multiforme, where it is combined with pembrolizumab in a controlled study design.