Glioma, MalignantNCT05557240
Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients
A study testing NeoPep Vaccine1 plus Poly-ICLC and NeoPep Vaccine2 plus Poly-ICLC in people with Glioma, Malignant and Antigen-specific Vaccines, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The primary objective of this study is to assess the safety and tolerability, feasibility of the NeoPep Vaccine in newly diagnosed glioblastoma (GB) patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma, Malignant, Antigen-specific Vaccines, Individualized Treatment
- What is being tested?
- NeoPep Vaccine1 plus Poly-ICLC and NeoPep Vaccine2 plus Poly-ICLC
- 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
- 13 Sep 2022to 12 Aug 2025
- Phase
- Interventional
- 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
- Ability of subject to understand and the willingness to sign written informed consent for study participation;
- Patients with newly diagnosed high-grade glioma confirmed by histopathological and imaging evaluation;
- Gross total resection (as defined by less than 1 cm2 residual tumor mass on the largest perpendicular axes in post-operative scan taken within 48 h post-surgery; standard MRI conformable to the present national and international guidelines is sufficient)；
- At least 0.5 g tumor tissue freshly cryopreserved during surgery，and could provide adequate amounts of PBMC；
- Patient is a candidate for and willing to receive standard CRT with TMZ followed by maintenance TMZ cycles;
- Age 18-70;
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- Life expectancy > 9 months;
- KPS≥70;
- Sufficient tumor tissue samples and peripheral blood samples can be obtained for sequencing analysis, or whole exome sequencing and RNA sequencing of tumor tissue samples and peripheral blood samples have been obtained, and the sequencing data meet the prediction requirements;
- Consent of women and men of reproductive age to use adequate and effective contraception during clinical trials;
- Normal laboratory values for hematology, liver and renal function (serum creatinine).In detail the following values apply as inclusion criteria:
- White blood cell count (WBC) ≥3.0×109/L；
- Absolutely neutrophil count≥1.0×109/L；
- Platelet count≥80×109/L；
- Hemoglobin content≥90g/L；
- Serum creatinine≤1.5 ULN or Creatinine clearance rate≥40 mL/min;
- TBil(total bilirubin)≤1.5 x ULN;
- Aspartic transaminase(AST)≤2.5x ULN or Alanine aminotransferase（ALT）≤2.5x ULN；Patients with liver metastases must have ≤5x ULN;
- Blood coagulation function :INR≤1.5x ULN；pT and APTT≤1.5x ULN;
- Urine protein< 2 +;if Urine protein≥2+,24-hour urinary protein must be less than 1g.
Who cannot join
- Patients treated with immunosuppressive agents (e.g., cyclosporin CsA, tacrolimus, rapamycin, azathioprine, etc.) within the previous month; Other immunotherapy within 3 months;
- History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 5 years unless the patient has been disease-free for 5 years;
- Participated in other clinical trials within 30 days prior to screening;
- Have a history of severe allergy or allergic constitution;
- Patients who have undergone splenectomy;
- Persons with primary or secondary immunodeficiency diseases (e.g. AIDS);Patients with autoimmune diseases;
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- Patients who received multiple oral, intramuscular, or intravenous corticosteroids within 30 days before the first dose; However, patients who received a single oral, intramuscular, or intravenous dose of dexamethasone of 5mg or less (or another hormone of equivalent potency) 14 days before the first dose were allowed; Allow inhaled corticosteroids to treat respiratory insufficiency (e.g., chronic obstructive pulmonary disease), or topical steroids;
- Patients with uncontrollable seizures, central nervous system disorders, or psychotic loss of cognition;
- Uncontrolled central nervous system metastases;
- Patients had a history of chronic alcohol or drug abuse in the 6 months before screening;
- With unstable systemic disease, such as active infection, liver cirrhosis, chronic renal failure, severe chronic pulmonary disease, unstable hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within one year, etc. ;
- According to this procedure, the number of candidate neoantigens that can be used to make personalized vaccines is less than 20;
- The investigator did not consider it appropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200000
Liang Gao, Phd, 13817934652, lianggaoh@126.com
About this study
Official title: Clinical Study on the Effect of Neoantigens on the Therapeutic Efficacy and Intestinal Microbiota in Patients With Newly Diagnosed Glioma
The primary objective of this study is to assess the safety and tolerability, feasibility of the NeoPep Vaccine in newly diagnosed glioblastoma (GB) patients.
Read the detailed description
This is a signelcenter, open-label, single arm, first-in-human phase I trial to investigate the safety, feasibility and immune response of the novel NeoPep Vaccine in patients with newly diagnosed GB.
Primary Endpoints:
Determine the safety and tolerability profile of NeoPep Vaccine1and 2 when administered with immunomodulators and Stupp standard treatment
Secondry Endpoints:
- Descriptive analysis of induced T-cell immune responses after vaccinations with NeoPep Vaccine1and 2 drug products plus immunomodulators and Stupp standard treatment.
- Overall survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.
- Progression-free survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.
After the standard chemoradiotherapy with TMZ has been completed, Vaccination was initiated 14 days before the first maintenanceTMZ cycle. It starts with the first NeoPep Vaccine1, followed by additional NeoPep Vaccine2 at a later time point and ends with the Last Endpoint Evaluation Visit (LEEV) of a patient.
- Being tested
- NeoPep Vaccine1 plus Poly-ICLC, NeoPep Vaccine2 plus Poly-ICLC
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoPep Vaccine1 plus Poly-ICLCDrug
Also called NPVAC1+Poly-ICLC
NPVAC1： NPVAC1 drug products are composed of 5 peptides from the HCMV warehouse， NPVAC1 vaccine will be applied before maintenance TMZ cycles after completion of chemoradiation therapy (CRT). Beginning on day 14 before the first maintenance TMZ cycle, patients will receive 7 vaccinations with NPVAC1 drug products during 6 weeks. 400 μg per peptide per vial are used.
Poly-ICLC:
Poly-ICLC（500ug）will be used as immunomodulator with all vaccinations.
NeoPep Vaccine2 plus Poly-ICLCDrug
Also called NPVAC2+Poly-ICLC
NPVAC2： NPVAC2 will be ready for use 2 months after enrollment, as these peptides have to be newly synthesized for each patient following identification of the mutanome and corresponding mutated peptides in the HLA ligandome. NPVAC2 drug products are composed 20 peptides de novo synthesized for an individual patient. Patients will be repeatedly vaccinated with NPVAC2 drug products beginning on day 33 of the 6 maintenance TMZ cycle.Patients will receive 9 vaccinations within 12 weeks. 400 μg per peptide per vial are used.
Poly-ICLC:
Poly-ICLC（500ug）will be used as immunomodulator with all vaccinations.
| Study group | Role | What they receive |
|---|---|---|
| NeoPep Vaccine1and 2 plus polyICLC concurrent to TMZ | Experimental | Not described Receives: Drug: NeoPep Vaccine1 plus Poly-ICLC; Drug: NeoPep Vaccine2 plus Poly-ICLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and toleration
Determine the safety and tolerability profile of NeoPep Vaccine1and 2 when administered with immunomodulators and Stupp standard treatment
Measured: Continously for about 40 weeks plus follow-up
Secondary outcomes (3)
T-cell immune response
Descriptive analysis of induced T-cell immune responses after vaccinations with NeoPep Vaccine1and 2 drug products plus immunomodulators and Stupp standard treatment.
Measured: till 24 months of vaccination
Overall survival(OS)
Overall survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.
Measured: till 24 months of vaccination
Progression-free survival（PFS）
Progression-free survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.
Measured: till 12 months of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start13 Sep 2022
- Primary completion12 Feb 2024 (estimated)
- Study completion12 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, MalignantStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou NeoVax Biotechnology Co. Ltd.
- Responsible party
- Principal investigator, LiangGao, Shanghai 10th People's Hospital
- Investigators
- Liang Gao, Phd, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557240
- Sponsor's protocol ID
- 10247
- Status last verified
- Oct 2022
- First submitted
- 25 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effect of Neoantigens on the Therapeutic Efficacy and Intestinal Microbiota in Patients With Newly Diagnosed Glioma
- ClinicalTrials.gov ID
- NCT05557240
- Acronym / sponsor ID
- 10247
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Hangzhou NeoVax Biotechnology Co. Ltd.
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 12 Feb 2024 (estimated)
- Study completion
- 12 Aug 2025 (estimated)
- First posted
- 27 Sep 2022 (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 primary objective of this study is to assess the safety and tolerability, feasibility of the NeoPep Vaccine in newly diagnosed glioblastoma (GB) patients.
Detailed description
This is a signelcenter, open-label, single arm, first-in-human phase I trial to investigate the safety, feasibility and immune response of the novel NeoPep Vaccine in patients with newly diagnosed GB.
Primary Endpoints:
Determine the safety and tolerability profile of NeoPep Vaccine1and 2 when administered with immunomodulators and Stupp standard treatment
Secondry Endpoints:
- Descriptive analysis of induced T-cell immune responses after vaccinations with NeoPep Vaccine1and 2 drug products plus immunomodulators and Stupp standard treatment.
- Overall survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.
- Progression-free survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.
After the standard chemoradiotherapy with TMZ has been completed, Vaccination was initiated 14 days before the first maintenanceTMZ cycle. It starts with the first NeoPep Vaccine1, followed by additional NeoPep Vaccine2 at a later time point and ends with the Last Endpoint Evaluation Visit (LEEV) of a patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeoPep Vaccine1and 2 plus polyICLC concurrent to TMZ | Experimental | Drug: NeoPep Vaccine1 plus Poly-ICLC, Drug: NeoPep Vaccine2 plus Poly-ICLC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Ability of subject to understand and the willingness to sign written informed consent for study participation;
- Patients with newly diagnosed high-grade glioma confirmed by histopathological and imaging evaluation;
- Gross total resection (as defined by less than 1 cm2 residual tumor mass on the largest perpendicular axes in post-operative scan taken within 48 h post-surgery; standard MRI conformable to the present national and international guidelines is sufficient)；
- At least 0.5 g tumor tissue freshly cryopreserved during surgery，and could provide adequate amounts of PBMC；
- Patient is a candidate for and willing to receive standard CRT with TMZ followed by maintenance TMZ cycles;
Key exclusion criteria (13 listed)
- Patients treated with immunosuppressive agents (e.g., cyclosporin CsA, tacrolimus, rapamycin, azathioprine, etc.) within the previous month; Other immunotherapy within 3 months;
- History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 5 years unless the patient has been disease-free for 5 years;
- Participated in other clinical trials within 30 days prior to screening;
- Have a history of severe allergy or allergic constitution;
- Patients who have undergone splenectomy;
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 |
|---|---|---|
| NeoPep Vaccine1 plus Poly-ICLCAlso: NPVAC1+Poly-ICLCNPVAC1： NPVAC1 drug products are composed of 5 peptides from the HCMV warehouse， NPVAC1 vaccine will be applied before maintenance TMZ cycles after completion of chemoradiation therapy (CRT). Beginning on day 14 before the first maintenance TMZ cycle, patients will receive 7 vaccinations with NPVAC1 drug products during 6 weeks. 400 μg per peptide per vial are used. Poly-ICLC: Poly-ICLC（500ug）will be used as immunomodulator with all vaccinations. | Drug | NeoPep Vaccine1and 2 plus polyICLC concurrent to TMZ |
| NeoPep Vaccine2 plus Poly-ICLCAlso: NPVAC2+Poly-ICLCNPVAC2： NPVAC2 will be ready for use 2 months after enrollment, as these peptides have to be newly synthesized for each patient following identification of the mutanome and corresponding mutated peptides in the HLA ligandome. NPVAC2 drug products are composed 20 peptides de novo synthesized for an individual patient. Patients will be repeatedly vaccinated with NPVAC2 drug products beginning on day 33 of the 6 maintenance TMZ cycle.Patients will receive 9 vaccinations within 12 weeks. 400 μg per peptide per vial are used. Poly-ICLC: Poly-ICLC（500ug）will be used as immunomodulator with all vaccinations. | Drug | NeoPep Vaccine1and 2 plus polyICLC concurrent to TMZ |
Primary outcome
Safety and toleration
Time frame: Continously for about 40 weeks plus follow-up
Determine the safety and tolerability profile of NeoPep Vaccine1and 2 when administered with immunomodulators and Stupp standard treatment
3 secondary outcomes
T-cell immune response
Time frame: till 24 months of vaccination
Overall survival(OS)
Time frame: till 24 months of vaccination
Progression-free survival（PFS）
Time frame: till 12 months of vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- 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.
Liang Gao, Phd principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoPep Vaccine1 plus Poly-ICLC and NeoPep Vaccine2 plus Poly-ICLC in people with Glioma, Malignant and Antigen-specific Vaccines, run by Shanghai 10th People's 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 20 inclusion and 13 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 12 Oct 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.
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 Lei Li, Phd (18817952194, Lei-Li@alumni.tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and toleration (time frame: Continously for about 40 weeks plus follow-up). 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 12 Oct 2022.