Clinical trial NCT02709616: Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC)
Official title: Personalized Cellular Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma (PerCellVac)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glioblastoma
Keywords: Glioblastoma
DC vaccine
tumor antigen
personalized vaccine
Lead sponsor: Guangdong 999 Brain Hospital
Sponsor class: OTHER
Collaborators: name: Jinan University Guangzhou
name: Beijing Tricision Biotherapeutics Inc
name: Zhuhai Trinomab Pharmaceutical Co., Ltd.
First posted: 2016-03-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dendritic cell-based cellular vaccine for tumor therapy has shown efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with newly diagnosed glioblastoma and then immunizing the patients with personalized DC-based cellular vaccine. Immune responses to tumor antigens will be monitored. Safety and efficacy will be observed in the study.

Detailed description: This is an open label, single-arm, single-institution, Phase I study designed to investigate the safety and efficacy of personalized cellular tumor vaccine for patients with newly diagnosed glioblastoma (GBM). Newly diagnosed GBM patients will undergo tumor resection. The tumors will be analyzed for the expression of a panel of glioma-associated antigens and immune-related genes. Post surgical treatment will be 6 weeks standard chemotherapy with temozolomide and concurrent radiotherapy and continue cycles of temozolomide within a 28-day window. Patients will undergo leukapheresis either after surgery or after concurrent radio/chemotherapy. Based on individual tumor antigen expression, in vitro transcribed mRNA will be generated and used to pulse in vitro generated DCs. The patients will be immunized i.d. and i.v. biweekly with DC cellular vaccines. Safety and efficacy will be monitored. The primary objective is to assess the safety of the personalized cellular vaccines. The secondary objective is to assess the specific T cell response to immunized vaccines. In addition, the antitumor efficacy of the vaccines will be measured using iRANO criteria, progression-free survival and overall survival.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed glioblastoma grade IV
* Patients at the age of 18-65.
* Patients must have undergone maximal surgical resection of the tumor.
* Patients with Karnofsky scores \> or =70
* Patients with normal range of hematologic and metabolic test results.
* Patients must have no corticosteroids treatment at least one week before vaccination.
* Patients capable of understanding the study and signed informed consent.

Exclusion Criteria:

* Breast feeding females.
* Pregnant women.
* Infectious diseases HIV, HBV, HCV
* Documented immunodeficiency
* Documented autoimmune disease
* Any serious or uncontrolled medical or psychiatric conditions, for example, severe pulmonary, cardiac or other systemic disease.
* Patient inability to participate as determined by PI discretion.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events and severe adverse events [safety and Tolerability]
timeFrame: 3 years since the beginning of the first vaccine
Secondary outcomes:
measure: Antitumor antigen specific T cell response
timeFrame: 4 weeks after the last vaccine
measure: Progression-free survival
timeFrame: 12 months since the beginning of the first vaccine.
measure: Overall survival
timeFrame: 3 years since the beginning of the first vaccine
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong 999 Brain Hospital
state: Guangdong
Study officials:
affiliation: Guangdong 999 Brain Hospital
name: Jian Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang QT, Nie Y, Sun SN, Lin T, Han RJ, Jiang J, Li Z, Li JQ, Xiao YP, Fan YY, Yuan XH, Zhang H, Zhao BB, Zeng M, Li SY, Liao HX, Zhang J, He YW. Tumor-associated antigen-based personalized dendritic cell vaccine in solid tumor patients. Cancer Immunol Immunother. 2020 Jul;69(7):1375-1387. doi: 10.1007/s00262-020-02496-w. Epub 2020 Feb 20.