High Grade GliomaPhase 1InSituVac1NCT03392545
Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)
A Phase 1 study testing Combined immune adjuvants and radiation in people with High Grade Glioma and Glioblastoma, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The study will investigate combined radiotherapy and immunotherapy on malignant gliomas. Immune adjuvants will be injected intratumorally and systemically to induce antitumor-specific immunity after radiation induced immunological tumor cell death (ICD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- High Grade Glioma, Glioblastoma, Glioma of Brainstem
- What is being tested?
- Combined immune adjuvants and radiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 Jun 2020
- 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
- Histopathologically confirmed glioma
- Age18-65
- Participants had undergone maximal surgical resection
- Amount of dexamethasone was not more than 2mg/ days
- Ability and willingness to sign informed consent
- Karnofsky Performance Score of 70 or more
- Normal liver and kidney function
- Not accepted other treatment plan during the immunotherapy
Who cannot join
- Not conforming to the standard
- Systemic illness or medical condition may pose additional risk,including cardiac, incompensated renal or liver function abnormalities;inflammatory and immune system diseases of rheumatic arthritis
- Received other drugs for glioma therapy 60days before participated
- Allergy to immune adjuvant
- Nervous system disease and diffuse leptomeningeal disease
- Amount of dexamethasone was more than 2mg/days during the immunotherapy
- Pregnant or lactation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Song Lin, M.D., 861067096509, linsong2005@126.com
Chun Zeng, M.D., 861067096509, zengchun79@aliyun.com
About this study
The study will investigate combined radiotherapy and immunotherapy on malignant gliomas. Immune adjuvants will be injected intratumorally and systemically to induce antitumor-specific immunity after radiation induced immunological tumor cell death (ICD). With radiation, tumor cells release tumor antigens that are captured by antigen presenting dendritic cells. Immune adjuvants promote the presentation of tumor antigens and the priming of antitumor T lymphocytes. The combined treatment induces and amplifies the specific antitumor immunity in patients with malignant gliomas, prolonging survivals of patients.
Read the detailed description
High grade gliomas, such as glioblatoma (GBM) is an aggressive malignancy with a poor prognosis. The current strategy for newly diagnosed GBM patients includes surgery, chemotherapy and radiotherapy. Unfortunately, after the standard treatmetn,the median survival of GBM is only about one year. Once relapsed, there is no standard therapy and survival is less than 9 months. Recently, personalized cancer immunotherapy has shown great promise in treating different types of cancers. However, effective immunotherapies for high grade gliomas, especially after progression, have yet to be established. Newly diagnosed GBM patients experience recurrence in five or seven months after standard treatment. We will investigate whether combining radiotherapy with intratumoral and systemic administration of immune adjuvants will improve the treatment outcome of high grade gliomas. We will use several immune adjuvants that activate innate and adaptive immunity.
- Being tested
- Combined immune adjuvants and radiation
- Keywords
- gliomas, radiotherapy, immunetherapy
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined immune adjuvants and radiationCombination product
Also called GM-CSF, poly I:C and radiation, CAR-T, TCR-T
24 hours before the radiation, patients will be administrated poly I:C or CAR-T or TCR-T intratumorally and receive granulocyte macrophage colony stimulating factor 5 days after the radiation.
| Study group | Role | What they receive |
|---|---|---|
| Combined immune adjuvants and radiation | Experimental | Patients with malignant gliomas will receive combined immune adjuvants (GM-CSF, TLR ligands) and radiation. The safety and efficacy will be analyzed. Receives: Combination Product: Combined immune adjuvants and radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-related Adverse Events
Adverse events during and after the combined treatment
Measured: 2 years
Secondary outcomes (2)
Progression-free Survival
Disease progression free survival time after combined treatment
Measured: 2 years
Overall Survival
Overall survival time after the combined treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Apr 2018
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Principal investigator, Song Lin, Beijing Tiantan Hospital
- Investigators
- Peijuan Ren, M.D., Study director, Beijing Tiantan HospitalSong Lin, M.D., Principal investigator, Beijing Tiantan HospitalYou-Wen He, M.D. Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392545
- Sponsor's protocol ID
- B0011
- Acronym
- InSituVac1
- Status last verified
- Jul 2019
- First submitted
- 11 Dec 2017
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zheng Y, Jiang H, Yang N, Shen S, Huang D, Jia L, Ling J, Xu L, Li M, Yu K, Ren X, Cui Y, Lan X, Lin S, Lin X. Glioma-derived ANXA1 suppresses the immune response to TLR3 ligands by promoting an anti-inflammatory tumor microenvironment. Cell Mol Immunol. 2024 Jan;21(1):47-59. doi: 10.1038/s41423-023-01110-0. Epub 2023 Dec 4.
PubMed 38049523Jiang H, Yu K, Cui Y, Ren X, Li M, Yang C, Zhao X, Zhu Q, Lin S. Combination of Immunotherapy and Radiotherapy for Recurrent Malignant Gliomas: Results From a Prospective Study. Front Immunol. 2021 May 7;12:632547. doi: 10.3389/fimmu.2021.632547. eCollection 2021.
PubMed 34025640
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)
- ClinicalTrials.gov ID
- NCT03392545
- Acronym / sponsor ID
- InSituVac1 / B0011
- Keywords
- gliomas, radiotherapy, immunetherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 8 Jan 2018 (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.
The study will investigate combined radiotherapy and immunotherapy on malignant gliomas. Immune adjuvants will be injected intratumorally and systemically to induce antitumor-specific immunity after radiation induced immunological tumor cell death (ICD). With radiation, tumor cells release tumor antigens that are captured by antigen presenting dendritic cells. Immune adjuvants promote the presentation of tumor antigens and the priming of antitumor T lymphocytes. The combined treatment induces and amplifies the specific antitumor immunity in patients with malignant gliomas, prolonging survivals of patients.
Detailed description
High grade gliomas, such as glioblatoma (GBM) is an aggressive malignancy with a poor prognosis. The current strategy for newly diagnosed GBM patients includes surgery, chemotherapy and radiotherapy. Unfortunately, after the standard treatmetn,the median survival of GBM is only about one year. Once relapsed, there is no standard therapy and survival is less than 9 months. Recently, personalized cancer immunotherapy has shown great promise in treating different types of cancers. However, effective immunotherapies for high grade gliomas, especially after progression, have yet to be established. Newly diagnosed GBM patients experience recurrence in five or seven months after standard treatment. We will investigate whether combining radiotherapy with intratumoral and systemic administration of immune adjuvants will improve the treatment outcome of high grade gliomas. We will use several immune adjuvants that activate innate and adaptive immunity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined immune adjuvants and radiation | Experimental | Combination Product: Combined immune adjuvants and radiationPatients with malignant gliomas will receive combined immune adjuvants (GM-CSF, TLR ligands) and radiation. The safety and efficacy will be analyzed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histopathologically confirmed glioma
- Age18-65
- Participants had undergone maximal surgical resection
- Amount of dexamethasone was not more than 2mg/ days
- Ability and willingness to sign informed consent
Key exclusion criteria (7 listed)
- Not conforming to the standard
- Systemic illness or medical condition may pose additional risk,including cardiac, incompensated renal or liver function abnormalities;inflammatory and immune system diseases of rheumatic arthritis
- Received other drugs for glioma therapy 60days before participated
- Allergy to immune adjuvant
- Nervous system disease and diffuse leptomeningeal 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 |
|---|---|---|
| Combined immune adjuvants and radiationAlso: GM-CSF, poly I:C and radiation, CAR-T, TCR-T24 hours before the radiation, patients will be administrated poly I:C or CAR-T or TCR-T intratumorally and receive granulocyte macrophage colony stimulating factor 5 days after the radiation. | Combination product | Combined immune adjuvants and radiation |
Primary outcome
Incidence of Treatment-related Adverse Events
Time frame: 2 years
Adverse events during and after the combined treatment
2 secondary outcomes
Progression-free Survival
Time frame: 2 years
Overall Survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Derived from this study: PubMed 38049523Zheng Y, Jiang H, Yang N, Shen S, Huang D, Jia L, Ling J, Xu L, Li M, Yu K, Ren X, Cui Y, Lan X, Lin S, Lin X. Glioma-derived ANXA1 suppresses the immune response to TLR3 ligands by promoting an anti-inflammatory tumor microenvironment. Cell Mol Immunol. 2024 Jan;21(1):47-59. doi: 10.1038/s41423-023-01110-0. Epub 2023 Dec 4.
- Derived from this study: PubMed 34025640Jiang H, Yu K, Cui Y, Ren X, Li M, Yang C, Zhao X, Zhu Q, Lin S. Combination of Immunotherapy and Radiotherapy for Recurrent Malignant Gliomas: Results From a Prospective Study. Front Immunol. 2021 May 7;12:632547. doi: 10.3389/fimmu.2021.632547. eCollection 2021.
- 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.
Peijuan Ren, M.D. study director
Beijing Tiantan Hospital
Song Lin, M.D. principal investigator
Beijing Tiantan Hospital
You-Wen He, M.D. Ph.D. principal investigator
Duke University
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 Combined immune adjuvants and radiation in people with High Grade Glioma and Glioblastoma, run by Beijing Tiantan 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 8 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: status not confirmed, as of the sponsor's last update on 11 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Song Lin, M.D. (+861067096509, linsong2005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-related Adverse Events (time frame: 2 years). 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 NCT03392545, which also lists 2 linked publications.
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 11 Jul 2019.