Malignant GliomaPhase 1NCT04943718
Personalized Vaccine for Patients With Recurrent Malignant Glioma
A Phase 1 study testing personalized vaccine in people with Malignant Glioma and Recurrent Glioma, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
A single-arm, single-center, open-labeled study will be conducted with an aim to investigate the feasibility, safety, and efficacy of the personalized vaccine for patients with recurrent malignant glioma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Glioma, Recurrent Glioma
- What is being tested?
- personalized 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
- 15 Jul 2021to 13 Jun 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-70;
- signed inform consent;
- patients with recurrent malignant glioma; have received surgery, radiotherapy, chemotherapy;
- patients' tumor tissue should have a high mutation load(>10 TMB); be genetically unstable; at least have 10 neoantigens;
- should be able to provide tumor tissue and peripheral blood for sequencing and flow cytometry analysis;
- at least three months post last operation; one month after the completion of the last anti-drug therapy or radiotherapy;
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- have not received any immune therapy;
- at least have one measurable lesion;
- KPS >60;
- estimated survival > 3 months
- patients should have adequate organ and bone marrow function;
Who cannot join
- female patient is breastfeeding or pregnant;
- known history of allergy to peptides or other stimulating factors (i.e. GM-CSF);
- known history of Graft-Versus-Host Disease (GVHD);
- participation in gene therapy;
- other malignancy;
- systemic disease: i.e., severe infection; HIV;
- other conditions upon investigator's judgement;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100054
Ye Cheng, M.D., 8610-83188114 ext. 2683, chengye@xwhosp.org
Qingtang Lin, M.D., Ph.D.
About this study
Official title: Personalized Vaccine for Patients With Recurrent Malignant Glioma: a Single-arm, Single-center, Open-labeled Study
A single-arm, single-center, open-labeled study will be conducted with an aim to investigate the feasibility, safety, and efficacy of the personalized vaccine for patients with recurrent malignant glioma.
- Conditions
- Malignant Glioma, Recurrent Glioma
- Being tested
- personalized vaccine
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized vaccineBiological
Based on genetic and transcriptional sequencing information, personalized peptide vaccines would be designed and produced; patients would be vaccinated on day 1, 4, 8 ,15, 22 and then on week 12, 20.
| Study group | Role | What they receive |
|---|---|---|
| personalized vaccine | Experimental | patients with recurrent malignant gliomas enrolled into this arm will receive the personalized vaccine through sub-cutaneous. Receives: Biological: personalized vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidences of advent events and severe advent events
would be monitored and measured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.X.)
Measured: from initiation of study treatment to 28 weeks post-vaccination
Secondary outcomes (4)
object response rate (ORR) according to iRANO criteria
ORR including complete response (CR) and partial response (PR) would be assessed and measured based on the conditions proposed by iRANO criteria
Measured: from initiation of study treatment to 24 weeks post-vaccination (last shot)
progression free survival (PFS)
time interval (measured in weeks) between initiation of study treatment to progression of disease
Measured: up to 48 weeks post-vaccination(last shot)
overall survival (OS)
time interval (measured in weeks) from initiation of study treatment to the death of patients
Measured: up to 48 weeks post-vaccination(last shot)
immune response based on the criteria encoded by GRT-C903 and GRT-R904
humoral and cellular immune responses including generation of specific antibodies, inflammatory factors, immune cells, will be measured as proposed by GRT-C903 and GRT-R904
Measured: Baseline to end of treatment (up to approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start15 Jul 2021 (estimated)
- Primary completion13 Jun 2023 (estimated)
- Study completion13 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Neoantigen Biotechnology Company
- Responsible party
- Principal investigator, Qingtang Lin, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943718
- Sponsor's protocol ID
- 2019-127
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Vaccine for Patients With Recurrent Malignant Glioma: a Single-arm, Single-center, Open-labeled Study
- ClinicalTrials.gov ID
- NCT04943718
- Acronym / sponsor ID
- 2019-127
- Conditions
- Malignant Glioma, Recurrent Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Neoantigen Biotechnology Company
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- 13 Jun 2023 (estimated)
- Study completion
- 13 Jun 2024 (estimated)
- First posted
- 29 Jun 2021 (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 single-arm, single-center, open-labeled study will be conducted with an aim to investigate the feasibility, safety, and efficacy of the personalized vaccine for patients with recurrent malignant glioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| personalized vaccine | Experimental | Biological: personalized vaccinepatients with recurrent malignant gliomas enrolled into this arm will receive the personalized vaccine through sub-cutaneous. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- age 18-70;
- signed inform consent;
- patients with recurrent malignant glioma; have received surgery, radiotherapy, chemotherapy;
- patients' tumor tissue should have a high mutation load(>10 TMB); be genetically unstable; at least have 10 neoantigens;
- should be able to provide tumor tissue and peripheral blood for sequencing and flow cytometry analysis;
Key exclusion criteria (7 listed)
- female patient is breastfeeding or pregnant;
- known history of allergy to peptides or other stimulating factors (i.e. GM-CSF);
- known history of Graft-Versus-Host Disease (GVHD);
- participation in gene therapy;
- other malignancy;
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 vaccineBased on genetic and transcriptional sequencing information, personalized peptide vaccines would be designed and produced; patients would be vaccinated on day 1, 4, 8 ,15, 22 and then on week 12, 20. | Biological | personalized vaccine |
Primary outcome
incidences of advent events and severe advent events
Time frame: from initiation of study treatment to 28 weeks post-vaccination
would be monitored and measured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.X.)
4 secondary outcomes
object response rate (ORR) according to iRANO criteria
Time frame: from initiation of study treatment to 24 weeks post-vaccination (last shot)
progression free survival (PFS)
Time frame: up to 48 weeks post-vaccination(last shot)
overall survival (OS)
Time frame: up to 48 weeks post-vaccination(last shot)
immune response based on the criteria encoded by GRT-C903 and GRT-R904
Time frame: Baseline to end of treatment (up to approximately 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
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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.
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 vaccine in people with Malignant Glioma and Recurrent Glioma, run by Xuanwu Hospital, Beijing 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 11 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 29 Jun 2021. 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 Qingtang Lin, M.D., Ph.D. (8610-83198114 ext. 2683, linqingtang@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidences of advent events and severe advent events (time frame: from initiation of study treatment to 28 weeks post-vaccination). 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 29 Jun 2021.