Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC)

• Sponsor: Guangdong 999 Brain Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02709616
• Collaborator: Jinan University Guangzhou (Other), Beijing Tricision Biotherapeutics Inc (Industry), Trinomab Biotech Co., Ltd. (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 40
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma	Biological: Personalized cellular vaccine	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Personalized Cellular Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma (PerCellVac)
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Oct 31, 2017
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Personalized cellular vaccine DC based cellular vaccine	Biological: Personalized cellular vaccine; Biological: DC-based cellular vaccine. Subjects will undergo surgical resection and standard 6-week chemo/radiotherapy and cycles of TMZ treatment. They will receive biweekly cellular vaccines.; Other Names: Tumor antigen pulsed DC vaccine

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment-emergent adverse events and severe adverse events [safety and Tolerability] [3 years since the beginning of the first vaccine]

   Incidence of adverse events and severe adverse events to measure safety and tolerability of mRNA-TAA pulsed autologous DC cellular vaccine

Secondary Outcome Measures

1. Antitumor antigen specific T cell response [4 weeks after the last vaccine]

   The frequency of peripheral CD8+ and CD4+ T cell response to the vaccine.

2. Progression-free survival [12 months since the beginning of the first vaccine.]

   Progression-free survival will be monitored for 1year.

3. Overall survival [3 years since the beginning of the first vaccine]

   Overall survival will be monitored for 3 years.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong 999 Brain Hospital	Guangzhou	Guangdong	China

Sponsors and Collaborators

• Guangdong 999 Brain Hospital
• Jinan University Guangzhou
• Beijing Tricision Biotherapeutics Inc
• Trinomab Biotech Co., Ltd.

Investigators

• Principal Investigator: Jian Zhang, M.D., Guangdong 999 Brain Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Publication of the trial results

Publications

None provided.

• Responsible Party: Jian Zhang, Jian Zhang, MD, Professor, Vice President of Guangdong 999 Brain Hospital, Chairman, Department of Surgery, Guangdong 999 Brain Hospital
• ClinicalTrials.gov Identifier: NCT02709616
• Other Study ID Numbers: Ag-mRNA-DC-999brain
• First Posted: Mar 16, 2016
• Last Update Posted: May 27, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Jian Zhang, Jian Zhang, MD, Professor, Vice President of Guangdong 999 Brain Hospital, Chairman, Department of Surgery, Guangdong 999 Brain Hospital: Glioblastoma; DC vaccine; tumor antigen; personalized vaccine
• Additional relevant MeSH terms: Glioblastoma; Vaccines

Study Results

No Results Posted as of May 27, 2022