GlioblastomaPhase 1PERCELLVACNCT02709616
Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC)
A Phase 1 study testing Personalized cellular vaccine in people with Glioblastoma, run by Guangdong 999 Brain Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Personalized cellular vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2016to 30 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Cellular Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma (PerCellVac)
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.
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- Personalized cellular vaccine
- Keywords
- Glioblastoma, DC vaccine, tumor antigen, personalized vaccine
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized cellular vaccineBiological
Also called Tumor antigen pulsed DC 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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized cellular vaccine | Experimental | DC based cellular vaccine Receives: Biological: Personalized cellular vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events and severe adverse events [safety and Tolerability]
Incidence of adverse events and severe adverse events to measure safety and tolerability of mRNA-TAA pulsed autologous DC cellular vaccine
Measured: 3 years since the beginning of the first vaccine
Secondary outcomes (3)
Antitumor antigen specific T cell response
The frequency of peripheral CD8+ and CD4+ T cell response to the vaccine.
Measured: 4 weeks after the last vaccine
Progression-free survival
Progression-free survival will be monitored for 1year.
Measured: 12 months since the beginning of the first vaccine.
Overall survival
Overall survival will be monitored for 3 years.
Measured: 3 years since the beginning of the first vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion31 Oct 2017
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong 999 Brain Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jinan University Guangzhou, Beijing Tricision Biotherapeutics Inc, Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Jian Zhang, Guangdong 999 Brain Hospital
- Investigators
- Jian Zhang, M.D., Principal investigator, Guangdong 999 Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709616
- Sponsor's protocol ID
- Ag-mRNA-DC-999brain
- Acronym
- PERCELLVAC
- Status last verified
- May 2022
- First submitted
- 7 Mar 2016
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32078016
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Cellular Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma (PerCellVac)
- ClinicalTrials.gov ID
- NCT02709616
- Acronym / sponsor ID
- PERCELLVAC / Ag-mRNA-DC-999brain
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, DC vaccine, tumor antigen, personalized vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Guangdong 999 Brain HospitalUniversity, hospital or other
- Collaborators
- Jinan University Guangzhou, Beijing Tricision Biotherapeutics Inc, Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized cellular vaccine | Experimental | Biological: Personalized cellular vaccineDC based cellular vaccine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- Breast feeding females.
- Pregnant women.
- Infectious diseases HIV, HBV, HCV
- Documented immunodeficiency
- Documented autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized cellular vaccineAlso: Tumor antigen pulsed DC vaccineBiological: 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. | Biological | Personalized cellular vaccine |
Primary outcome
Incidence of treatment-emergent adverse events and severe adverse events [safety and Tolerability]
Time frame: 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
3 secondary outcomes
Antitumor antigen specific T cell response
Time frame: 4 weeks after the last vaccine
Progression-free survival
Time frame: 12 months since the beginning of the first vaccine.
Overall survival
Time frame: 3 years since the beginning of the first vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Results publication: PubMed 32078016Wang 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.
- Publication of the trial resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Zhang, M.D. principal investigator
Guangdong 999 Brain Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Personalized cellular vaccine in people with Glioblastoma, run by Guangdong 999 Brain Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events and severe adverse events [safety and Tolerability] (time frame: 3 years since the beginning of the first vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02709616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.