drugset / Trial / NCT04963413
RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP | Cell therapy | — | — |
| Background | sargramostim | Protein / enzyme biologic | — | — |