Clinical trial NCT02808364: Personalized Cellular Vaccine for Recurrent Glioblastoma (PERCELLVAC2)
Official title: Personalized Cellular Vaccine Therapy in Treating Patients With Recurrent Glioblastoma (PerCellVac2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glioblastoma
Keywords: Recurrent glioblastoma
DC vaccine
tumor antigen
personalized vaccine
Lead sponsor: Guangdong 999 Brain Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tricision Biotherapeutics Inc
name: Zhuhai Trinomab Pharmaceutical Co., Ltd.
name: Jinan University Guangzhou
First posted: 2016-06-21
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: The treatment option for recurrent glioblastoma is limited. Immune cell based therapy for glioblastoma has shown some efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with recurrent glioblastoma and then immunizing the patients with personalized antigen pulsed DCs. Immune responses to the immunized antigens will be monitored. Safety and efficacy will be observed in this 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 vaccines for patients with recurrent glioblastoma (GBM). Recurrent 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. Patients will undergo leukapheresis to collect mononuclear cells for DC generation. Based on the expression profiles of tumor-associated antigens, in vitro transcribed mRNA will be generated to pulse autologous DCs. Patients will be conditioned with immune adjuvants before and during immunization. Patients will receive biweekly vaccines. The antitumor specific T cell responses will be measured. Safety and efficacy will be monitored. The objective is to assess the safety of the personalized cellular vaccines and T cell responses. The efficacy of the vaccines will be evaluated using iRANO criteria, progression-free survival and overall survival.

Eligibility criteria: Inclusion Criteria:

* Recurrent glioblastoma grade IV
* Patients at the age of 18-65.
* Patients undergo tumor resection.
* 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.