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Monocyte Antigen Carrier Cells for Newly Diagnosed GBM

NCT04741984 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-05-15

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Michael Gunn

    lead OTHER

Principal Investigators

  • Annick S Desjardins, MD, FRCPC · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2025-05-31
Completion
2025-11-30
FDA Drug
Yes

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Entities

Diseases

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 NCT04741984 on ClinicalTrials.gov