cropped color_logo_with_background.png

Clinical Trial Finder

Personalized Cellular Vaccine for Recurrent Glioblastoma (PERCELLVAC2)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02808364
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Guangdong 999 Brain Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jian Zhang, M.D.
Principal Investigator Affiliation Guangdong 999 Brain Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Completed
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: Personalized cellular vaccine

Subjects will undergo tumor resection. They will receive biweekly cellular vaccines consisting of mRNA tumor antigen pulsed autologous DCs.

Interventions

Biological: - Personalized cellular vaccine

Patients with recurrent glioblastoma will undergo tumor resection and receive tumor antigen pulsed cellular vaccines.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Guangdong 999 Brain Hospital, Guangzhou, Guangdong, China

Status

Address

Guangdong 999 Brain Hospital

Guangzhou, Guangdong,

Powered By