drugset / Trial / NCT04277221
ADCTA for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM)
RandomizedParallel-groupOpen-labelTreatment
Summary
To confirm the result of previous Phase I/II and phase II clinical trials, this trial is to test the efficacy and safety of ADCTA immunotherapy plus the standard therapy in comparison with standard therapy alone in patients with recurrent GBM.
Timeline
- Start
- 2019-09-19
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
Publications
- Results Chang CN, Huang YC, Yang DM, Kikuta K, Wei KJ, Kubota T, Yang WK. A phase I/II clinical trial investigating the adverse and therapeutic effects of a postoperative autologous dendritic cell tumor vaccine in patients with malignant glioma. J Clin Neurosci. 2011 Aug;18(8):1048-54. doi: 10.1016/j.jocn.2010.11.034. Epub 2011 Jun 28.
- Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous Dendritic Cell/Tumor Antigen | Cell therapy | 1e+07 cells | Subcutaneous |
| Subject | Autologous Dendritic Cell/Tumor Antigen | Cell therapy | 2e+07 cells | Subcutaneous |