Evaluate the Efficacy and Safety of ADCV01 As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients

ConditionGBM
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-75
SponsorEver Supreme Bio Technology Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • autologous dendritic cells

Treatment groups

24 Participants
are divided into 2 treatment groups