NCT04741984

Monocyte Antigen Carrier Cells for Newly Diagnosed GBM

The DEMAND Study: Dose Escalation Study of Monocyte Antigen Carrier Cells for Newly Diagnosed Glioblastoma With Unmethylated MGMT Gene Promoter

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Michael Gunn · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine the maximum tolerated dose (MTD) of MT-201-GBM (pp65CMV antigen monocytes) that will be administered to patients newly diagnosed with a type of brain tumor called glioblastoma (GBM) that has an unmethylated MGMT (O\[6\]-methylguanine-DNA methyltransferase) (MGMT) gene promoter.

Detailed description

The investigational vaccine (MT-201-GBM) in this study is made from a type of immune cell called monocytes, which have been engineered to express a cytomegalovirus (CMV) protein. The monocyte vaccines are made from the patient's own cells, which are collected through a procedure called leukapheresis. During leukapheresis, the patient's blood is collected into a machine that removes white blood cells and then returns the remainder of the blood back to the individual. The leukapheresis procedure is not typically associated with any discomfort or pain. The white blood cells collected from leukapheresis are used to generate the patient's monocyte vaccine. After leukapheresis, patients receive standard radiation therapy combined with temozolomide for about 6 weeks, followed by one cycle of temozolomide for 21 days. About 2 days later, patients will receive the first monocyte vaccine, followed by 2 more monocyte vaccines every 4 weeks.

Conditions

• Glioblastoma
• Glioma, Malignant

Interventions

Type	Name	Description
BIOLOGICAL	MT-201-GBM monocyte vaccine	monocytes isolated from patient's leukapheresis loaded with CMV pp65-LAMP (Lysosomal-associated Membrane Protein) mRNA (Messenger Ribonucleic Acid)

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-05-01
• Completion: 2025-11-01
• First posted: 2021-02-05
• Last updated: 2023-05-15

Regulatory

• FDA-regulated drug study