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
Patients are ≥ 20 and ≤ 75 years of age at brain tumor resection surgery.
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.
Patients undergo tumor resection by aid of neuro-navigation without receiving any intracranial implantation therapies (e.g., BCNU wafer).
Only one GBM tumor number.
Number of GBM is more than one
Patient who has participated in other investigational studies within 4 weeks prior to pre-screening
Patient with known or suspected hypersensitivity to ADCV01 or its excipients
Patient who has a history of hypersensitivity reaction (e.g., urticarial, allergic reaction including anaphylaxis, toxic epidermal necrosis, and Stevens-Johnson syndrome) to dacarbazine (DTIC) or any components of medications of temozolomide and bevacizumab
Parallel
autologous dendritic cells
Biological/VaccineThe total 10 doses (1 mL/dose; 2±0.5 × 10\^7 cell/dose) of ADCV01 will be administered to patients assigned to the investigational group. The ADCV01 will be administered to the bilateral subaxillary subcutaneous regional lymph nodes (half of volume about 0.5 mL of ADCV01) once weekly for the first 4 doses, and the following 2 treatments will be administered bi-weekly. The last 4 treatments will be administered every 4 weeks.
One-year progression-free survival (PFS) rate
The PFS is defined as the time from randomization until the tumor objective progression or death, whichever occurs first.
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