GlioblastomaPhase 1/2NCT04388033
Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
A Phase 1/2 study testing Dendritic Cell/Tumor Fusion Vaccine, Interleukin-12 and Temozolomide in people with Glioblastoma and Glioma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
A multi-center, open-label, single-arm, phase I/II clinical study is designed to test the safety and immunogenicity of an investigational Dendritic and Glioma Cells Fusion vaccine given with IL-12 for treatment-naïve patients after resection of glioblastoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma, Glioma, Neoplasms, Neuroepithelial
- What is being tested?
- Dendritic Cell/Tumor Fusion Vaccine, Interleukin-12 and Temozolomide
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2020to Dec 2023
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years; Male or Female.
- Treatment-naïve patients after Resection of Glioblastoma.
- Histologically confirmed Glioblastoma.
- KPS ≥ 60
- White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
- Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
- Patients must be able to understand the investigational nature of the study and provide informed consent.
Who cannot join
- Those who are allergic constitution, or allergic to biological products, or have contraindications to CT and MRI1 contrast agents.
- Those with severe autoimmune diseases or immunodeficiency diseases.
- Those who are expected to take systemic corticosteroids within three months.
- Those who needs long-term usage of immunosuppressive agents.
- Those with infectious diseases, including syphilis, AIDS, hepatitis B, hepatitis C, etc.
- Those who plan to receive any other anti-tumor treatment during the trial.
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- Combined with serious primary diseases of cardiovascular, liver and kidney, and liver function (ALT, AST, Y-GT) exceeding 1.5 times of the upper limit: BUN or Cr exceeding 1.5 times of the upper limit of normal value.
- Patients with other malignant tumors.
- Those with active infections, etc.
- Suspected or confirmed a history of alcohol and drug abuse.
- Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
- Women who are pregnant or nursing.
- Women of childbearing age who refuse to contraception.
- Active participation in another clinical treatment trials.
- According to the judgment of the investigator, other conditions that the plan cannot be followed.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310051
Hong Shen, MD, 8613805730380, sh_2nd@126.com
Chongran Sun, MD, 8615925612402, 2307101@zju.edu.cn
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310051
Caixing Sun, MD, 8613777820122, 2226124552@qq.com
Liang Xia, MD, 8615168272549, xialiang@zjcc.org.cn
About this study
A multi-center, open-label, single-arm, phase I/II clinical study is designed to test the safety and immunogenicity of an investigational Dendritic and Glioma Cells Fusion vaccine given with IL-12 for treatment-naïve patients after resection of glioblastoma.
Read the detailed description
This clinical trail includes two phases: basic treatment phase and immunotherapy phase. In basic treatment phase, patients will receive concomitant radiation and TMZ-chemotherapy. In immunotherapy phase, besides maintenance chemotherapy with TMZ, Fusion cells will be administered with IL-12 to enhance the immunity of patients.
- Conditions
- Glioblastoma, Glioma, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Neoplasms, Neoplasms, Nerve Tissue
- Being tested
- Dendritic Cell/Tumor Fusion Vaccine, Interleukin-12, Temozolomide
- Medical subject headings
- Glioblastoma, Glioma, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Neoplasms, Neoplasms, Nerve Tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic Cell/Tumor Fusion VaccineBiological
Also called DC/tumor cell fusion vaccine
Vaccine is derived from the participants dendritic cells and tumor cells.
Interleukin-12Drug
Also called IL-12
Given subcutaneously at dose of 6ug twice for interval of one hour.
TemozolomideDrug
Also called TMZ
Following concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days) , maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Safety Evaluation Group | Experimental | Basic treatment phase:
The patients have surgery followed by concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days).
Immunotherapy phase:
Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle. Fusion cells will be suspended in 0.5 mL normal saline and then injected intradermally close to a cervical lymph node. IL-12 will be injected subcutaneously at the same side at dose of 6ug twice for interval of one hour. Receives: Biological: Dendritic Cell/Tumor Fusion Vaccine; Drug: Interleukin-12; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE) / Serious Adverse Events (SAE)
AE/SAE associated with the intervention will be captured throughout the treatment portion of the study. All adverse events will be then compiled and these patients will be recorded.
Measured: 2-3 years
Progression free survival (PFS) at 6 months
Assessed from this study start date to the date of the first observation of clinical or radiographic disease progression or death due to any cause. Patients will be censored at the time they are last known to be alive and progression free (if withdrawn or lost to follow-up).
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Secondary outcomes (2)
Immunological Assays
Assays including Flow Cytometry and Elispot will be employed to determine if cellular and humoral immunity were induced by serial vaccination with DC/Tumor Fusion Cells and IL-12.
Measured: 2-3 years
Overall survival (OS) time
Assessed from this study start date to date of death of any cause. Patients will be censored at the time that they are last known to be alive (if withdrawn or lost to follow-up).
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Medical Biotechnology Co., Ltd, CyTIX.Inc
- Responsible party
- Sponsor
- Investigators
- Hong Shen, MD, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388033
- Sponsor's protocol ID
- MDKZJU-DCf12-2019408
- Status last verified
- Dec 2019
- First submitted
- 11 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
- ClinicalTrials.gov ID
- NCT04388033
- Acronym / sponsor ID
- MDKZJU-DCf12-2019408
- Conditions
- Glioblastoma, Glioma, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Neoplasms, Neoplasms, Nerve Tissue
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Hangzhou Medical Biotechnology Co., Ltd, CyTIX.Inc
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 May 2020 (actual)
- 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.
A multi-center, open-label, single-arm, phase I/II clinical study is designed to test the safety and immunogenicity of an investigational Dendritic and Glioma Cells Fusion vaccine given with IL-12 for treatment-naïve patients after resection of glioblastoma.
Detailed description
This clinical trail includes two phases: basic treatment phase and immunotherapy phase. In basic treatment phase, patients will receive concomitant radiation and TMZ-chemotherapy. In immunotherapy phase, besides maintenance chemotherapy with TMZ, Fusion cells will be administered with IL-12 to enhance the immunity of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety Evaluation Group | Experimental | Biological: Dendritic Cell/Tumor Fusion Vaccine, Drug: Interleukin-12, Drug: TemozolomideBasic treatment phase: The patients have surgery followed by concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days). Immunotherapy phase: Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle. Fusion cells will be suspended in 0.5 mL normal saline and then injected intradermally close to a cervical lymph node. IL-12 will be injected subcutaneously at the same side at dose of 6ug twice for interval of one hour. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years; Male or Female.
- Treatment-naïve patients after Resection of Glioblastoma.
- Histologically confirmed Glioblastoma.
- KPS ≥ 60
- White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
Key exclusion criteria (15 listed)
- Those who are allergic constitution, or allergic to biological products, or have contraindications to CT and MRI1 contrast agents.
- Those with severe autoimmune diseases or immunodeficiency diseases.
- Those who are expected to take systemic corticosteroids within three months.
- Those who needs long-term usage of immunosuppressive agents.
- Those with infectious diseases, including syphilis, AIDS, hepatitis B, hepatitis C, etc.
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 |
|---|---|---|
| Dendritic Cell/Tumor Fusion VaccineAlso: DC/tumor cell fusion vaccineVaccine is derived from the participants dendritic cells and tumor cells. | Biological | Safety Evaluation Group |
| Interleukin-12Also: IL-12Given subcutaneously at dose of 6ug twice for interval of one hour. | Drug | Safety Evaluation Group |
| TemozolomideAlso: TMZFollowing concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days) , maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle. | Drug | Safety Evaluation Group |
Primary outcome
Adverse Events (AE) / Serious Adverse Events (SAE)
Time frame: 2-3 years
AE/SAE associated with the intervention will be captured throughout the treatment portion of the study. All adverse events will be then compiled and these patients will be recorded.
Progression free survival (PFS) at 6 months
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Assessed from this study start date to the date of the first observation of clinical or radiographic disease progression or death due to any cause. Patients will be censored at the time they are last known to be alive and progression free (if withdrawn or lost to follow-up).
2 secondary outcomes
Immunological Assays
Time frame: 2-3 years
Overall survival (OS) time
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Hong Shen, MD study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dendritic Cell/Tumor Fusion Vaccine, Interleukin-12 and Temozolomide in people with Glioblastoma and Glioma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites 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 15 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Shen, MD (8613805730380, sh_2nd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) / Serious Adverse Events (SAE) (time frame: 2-3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2020.