Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC)

Guangdong 999 Brain Hospital

Status and phase

Completed

Phase 1

Conditions

Glioblastoma

Treatments

Biological: Personalized cellular vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02709616

Ag-mRNA-DC-999brain

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.