drugset / Trial / NCT03615404

Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma

NCT03615404

Phase 1 Completed 11 enrolled Gary Archer Ph.D.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the feasibility and safety of administering CMV RNA-pulsed dendritic cells (DCs), also known as CMV-DCs, to children and young adults up to 35 years old with nWHO Grade IV glioma, recurrent malignant glioma, or recurrent medulloblastoma. Evidence for efficacy will also be sought. This will be a phase 1 study evaluating CMV-DC administration with tetanus toxoid (Td) preconditioning and Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) adjuvant in children and young adults up to 35 years old with WHO grade IV glioma, recurrent malignant glioma, or recurrent medulloblastoma. This safety study will enroll a maximum of 10 patients.

Timeline

Start
2018-10-05
Primary completion
2019-11-19
Completion
2020-07-02

Drugs

EvaluationDrugModalityDoseRoute
Subject CMV-DCs Cell therapy
Background Td Vaccine
Background sargramostim Protein / enzyme biologic