drugset / Trial / NCT04963413

RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.

NCT04963413

NaSingle-groupOpen-labelTreatment

Summary

In prior trials of CMV RNA-pulsed dendritic cell vaccines, there has been a narrow window between surgery and initiation of chemoradiation to enroll patients and perform leukapheresis (to obtain cells needed to generate investigational vaccine). Patients who had started chemoradiation were not eligible to participate. In this study, the investigators propose to conduct a pilot study to evaluate the ability to generate pp65 full-length LAMP RNA-pulsed DCs in patients who have completed standard external beam radiation and concomitant temozolomide who are receiving adjuvant temozolomide chemotherapy at the time of enrollment.

Timeline

Start
2022-01-13
Primary completion
2023-09-28
Completion
2023-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP Cell therapy
Background sargramostim Protein / enzyme biologic

Indications