Evaluate the Efficacy and Safety of ADCV01 As an Add-On Treatment for Primary Glioblastoma
This study is designed with open-label and randomized parallel group to evaluate the efficacy and safety of autologous dendritic cell vaccination (ADCV01) as an add-on treatment for primary glioblastoma multiforme
| Condition(s) | GBM |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This study is designed with open-label and randomized parallel group to evaluate the efficacy and safety of autologous dendritic cell vaccination (ADCV01) as an add-on treatment for primary glioblastoma multiforme |
| Who can participate | Inclusion Criteria: Stage I (Pre-screening) 1. Patients are ≥ 20 and ≤ 75 years of age at brain tumor resection surgery. 2. Patients with newly diagnosed single, primary, WHO grade IV, glioblastoma (except for locating on brainstem or cerebellum) scheduled to undergo craniotomy tumor excision, and are willing to preserve the resected tumor cells enabling the production of ADCV01. 3. Patients undergo tumor resection by aid of neuro-navigation without receiving any intracranial implantation therapies (e.g., BCNU wafer). 4. Only one GBM tumor number. 5. Patients must be able to understand and sign the informed consent documents and aware of the investigational nature of the study. 6. Patients have the expected life expectancy of \> 12 weeks at the pre-screening visit as judged by the investig |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Lead sponsor | Ever Supreme Bio Technology Co., Ltd. |
| Locations | Taichung, Non-US, Taiwan; Taoyuan, Non-US, Taiwan; Taichung, Taiwan |
| Start date | 2019-06-06 |
| NCT ID | NCT04115761 |
| Official listing | https://clinicaltrials.gov/study/NCT04115761 |