Advanced Malignant Solid TumorsNCT05749627
Using Neoantigen Peptide Vaccine/neoantigen-based DC to Treat Advanced Malignant Solid Tumors
A study testing Neoantigen peptide vaccine and Neoantigen-based DC immune preparation in people with Advanced Malignant Solid Tumors, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
In this study, the investigators provide a personalized tumor neoantigen peptide vaccine/neoantigen-based DC treatment to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- Neoantigen peptide vaccine and Neoantigen-based DC immune preparation
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- With inoperable advanced malignant solid tumors, including melanoma, gastrointestinal tumor, breast cancer, pancreatic cancer, cervical cancer, lung cancer, etc.
- Failed in standard treatment or voluntarily give up other treatment, and been longer than 2 weeks from the end of the last anti-tumor treatment
- Had disease progression prior to treatment
- Expected survival ≥ 3 months
- ECOG performance status of 0, 1, or 2
- With a negative pregnancy test for females of childbearing age
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- Able to take effective contraceptive measures and ensure that there is no birth plan within half a year of the study
- Not positive for HIV, HBV, HCV, or TP
- ALT/AST ≤ 2.5 times the upper limit of normal
- ALP ≤ 2.5 times the upper limit of normal
- Serum creatinine ≤1.6 mg/dL
- Total bilirubin ≤ 1.5 mg/dL
- In the absence of granulocyte colony-stimulating factor support, proportion of lymphocytes > 20%, absolute neutrophil count ≥ 1x10^9/L, white blood cell count ≥ 3x10^9/L, platelet count ≥ 100×10^9/L, hemoglobin > 8.0 g/dL, CD4+ cell count > 200/μL
- With normal coagulation test and ECG
- Able to understand and willing to sign a written informed consent form
Who cannot join
- Pregnant or breastfeeding women
- Patients with brain metastases
- Had immunosuppressant therapy within 1 month or received other immunotherapy within 3 months
- Participated in other clinical study within 30 days
- With severe allergies or histories of severe allergy
- With splenectomy
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- With primary or secondary immunodeficiency diseases or autoimmune diseases (including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, psoriasis, uncontrolled asthma, etc.)
- Had oral, intramuscular, or intravenous corticosteroids within 1 month. However, inhaled corticosteroids are allowed to treat respiratory insufficiency (such as chronic obstructive pulmonary disease), as well as topical steroids
- With uncontrollable epilepsy, central nervous system disorder, or neurological disease with loss of cognitive ability
- With a history of chronic alcohol or drug abuse within 6 months
- With unstable systemic diseases (including active infection, liver cirrhosis, chronic renal failure, severe chronic pulmonary disease, unstable hypertension, unstable angina, congestive heart failure, myocardial infarction within 1 year, etc.)
- With a history of other malignant tumors in the past 5 years (excluding those who have been clinically cured, and squamous cell carcinoma or skin basal cell carcinoma)
- Those the researcher believed inappropriate to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aiping Le contact
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Sujun Li, PhD, 8617600699826, 17600699826@163.com
Aiping Le
About this study
Official title: A Clinical Study of Personalized Tumor Neoantigen Peptide Vaccine/neoantigen-based Dendritic Cells in the Treatment of Advanced Malignant Solid Tumors
In this study, the investigators provide a personalized tumor neoantigen peptide vaccine/neoantigen-based DC treatment to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the neoantigen-based DC treatment.
Read the detailed description
This study is conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials.
20 patients with primary or metastatic melanoma, gastrointestinal tumor, breast cancer, cervical cancer, pancreatic cancer, lung cancer, or other malignant tumors will be recruited in this study. With doctor's assessment, a personalized tumor neoantigen peptide vaccine or neoantigen-based DC treatment plan will be designed for each participant：
- Collecting venous blood samples;
- Blood PBMC exome sequencing;
- RNA transcriptome sequencing;
- Classifying HLA alleles;
- Performing bioinformatics analysis, finding meaningful mutations and about 10 neoantigen sequences for each patient;
- Synthesizing peptide neoantigens;
- Preparation of the personalized tumor neoantigen peptide vaccine or generating the personalized tumor neoantigen DC therapeutic immune preparation.
Participants will receive 5-6 subcutaneous injections of the vaccine or DC preparation within a treatment period of 14 weeks. After treatment, participants will have 3 follow-up visits during 9-months. Venous blood collection, physical examination, ECOG Performance Status Scale assessment, CT/MRI scan, X-ray examination, laboratory examination, and other necessary examinations are required at each follow-up visit.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- Neoantigen peptide vaccine, Neoantigen-based DC immune preparation
- Keywords
- Neoantigen Peptide Vaccine, Neoantigen-based Dendritic Cells, Therapeutic immune preparation, Advanced Malignant Solid Tumors, Progression-free Survival, Overall Survival, Overall Response Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen peptide vaccineDrug
Personalized tumor neoantigen peptide vaccine
Neoantigen-based DC immune preparationDrug
Personalized tumor neoantigen DC therapeutic immune preparation
| Study group | Role | What they receive |
|---|---|---|
| Neoantigen peptide vaccine/neoantigen-based DC treatment | Experimental | Patients assigned to the neoantigen peptide vaccine/neoantigen-based DC treatment group will receive 5-6 subcutaneous injections of neoantigen peptide vaccine or neoantigen-based DC immune preparation within a 14-week treatment period. Receives: Drug: Neoantigen peptide vaccine; Drug: Neoantigen-based DC immune preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival (PFS) is the time from the inoculation of the individualized neoantigen immune preparation to disease progression or death from various causes for all patients. Tumor assessment is performed according to the RECIST1.1 standard. The analysis of this indicator includes results of tumor assessments performed during the treatment period and the follow-up period. If a patient has several indicators that can be judged as disease progression (PD), the indicator that appears first will be used for PFS analysis. Relapse, new tumors, or death are considered to have reached the end of the study. For patients who had not experienced disease progression at the end of the study, the last time the patient had no disease progression was used as censoring data.
Measured: 9 months after treatment
Overall response rate
Overall response rate is the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including complete response (CR) and partial response (PR) cases. Response Evaluation Criteria in Solid Tumors (RECIST 1.1) was used to evaluate the objective response of tumors. Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation is divided into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).
Measured: 1 week after treatment
Tumor makers
CEA，CA19-9，CA125
Measured: 9 months after treatment
Secondary outcomes (5)
Overall survival
Overall survival is the time from inoculation of the individualized neoantigen immune preparation to death due to various causes for all patients.
Measured: 9 months after treatment
Disease control rate
Disease control rate is the percentage of patients who have a complete response (CR), partial response (PR), and stable disease (SD) to the treatment.
Measured: 1 week after treatment
Tumor imaging
CT/MRI scan, X-ray examination etc.
Measured: 9 months after treatment
Peripheral blood cytokines
Changes in peripheral blood cytokines after treatment, including IFN-γ, TNF, IL-2, etc.
Measured: 9 months after treatment
ECOG
Eastern Cooperative Oncology Group (ECOG) Performance Status Scale. This scale describes patients' level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Researchers worldwide consider the ECOG Performance Status Scale when planning cancer clinical trials to study new treatments. There are 6 grades in ECOG, the minimum value is 0 and the maximum value is 5, while a higher score indicates a worse condition.
Measured: 9 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Dengding BioAI Co.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749627
- Sponsor's protocol ID
- IIT-2021-087
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Personalized Tumor Neoantigen Peptide Vaccine/neoantigen-based Dendritic Cells in the Treatment of Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05749627
- Acronym / sponsor ID
- IIT-2021-087
- Conditions
- Advanced Malignant Solid Tumors
- Keywords
- Neoantigen Peptide Vaccine, Neoantigen-based Dendritic Cells, Therapeutic immune preparation, Advanced Malignant Solid Tumors, Progression-free Survival, Overall Survival, Overall Response Rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Collaborators
- Shanghai Dengding BioAI Co.
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Mar 2023 (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.
In this study, the investigators provide a personalized tumor neoantigen peptide vaccine/neoantigen-based DC treatment to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the neoantigen-based DC treatment.
Detailed description
This study is conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials.
20 patients with primary or metastatic melanoma, gastrointestinal tumor, breast cancer, cervical cancer, pancreatic cancer, lung cancer, or other malignant tumors will be recruited in this study. With doctor's assessment, a personalized tumor neoantigen peptide vaccine or neoantigen-based DC treatment plan will be designed for each participant：
- Collecting venous blood samples;
- Blood PBMC exome sequencing;
- RNA transcriptome sequencing;
- Classifying HLA alleles;
- Performing bioinformatics analysis, finding meaningful mutations and about 10 neoantigen sequences for each patient;
- Synthesizing peptide neoantigens;
- Preparation of the personalized tumor neoantigen peptide vaccine or generating the personalized tumor neoantigen DC therapeutic immune preparation.
Participants will receive 5-6 subcutaneous injections of the vaccine or DC preparation within a treatment period of 14 weeks. After treatment, participants will have 3 follow-up visits during 9-months. Venous blood collection, physical examination, ECOG Performance Status Scale assessment, CT/MRI scan, X-ray examination, laboratory examination, and other necessary examinations are required at each follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoantigen peptide vaccine/neoantigen-based DC treatment | Experimental | Drug: Neoantigen peptide vaccine, Drug: Neoantigen-based DC immune preparationPatients assigned to the neoantigen peptide vaccine/neoantigen-based DC treatment group will receive 5-6 subcutaneous injections of neoantigen peptide vaccine or neoantigen-based DC immune preparation within a 14-week treatment period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- With inoperable advanced malignant solid tumors, including melanoma, gastrointestinal tumor, breast cancer, pancreatic cancer, cervical cancer, lung cancer, etc.
- Failed in standard treatment or voluntarily give up other treatment, and been longer than 2 weeks from the end of the last anti-tumor treatment
- Had disease progression prior to treatment
- Expected survival ≥ 3 months
- ECOG performance status of 0, 1, or 2
Key exclusion criteria (13 listed)
- Pregnant or breastfeeding women
- Patients with brain metastases
- Had immunosuppressant therapy within 1 month or received other immunotherapy within 3 months
- Participated in other clinical study within 30 days
- With severe allergies or histories of severe allergy
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 |
|---|---|---|
| Neoantigen peptide vaccinePersonalized tumor neoantigen peptide vaccine | Drug | Neoantigen peptide vaccine/neoantigen-based DC treatment |
| Neoantigen-based DC immune preparationPersonalized tumor neoantigen DC therapeutic immune preparation | Drug | Neoantigen peptide vaccine/neoantigen-based DC treatment |
Primary outcome
Progression-free survival
Time frame: 9 months after treatment
Progression-free survival (PFS) is the time from the inoculation of the individualized neoantigen immune preparation to disease progression or death from various causes for all patients. Tumor assessment is performed according to the RECIST1.1 standard. The analysis of this indicator includes results of tumor assessments performed during the treatment period and the follow-up period. If a patient has several indicators that can be judged as disease progression (PD), the indicator that appears first will be used for PFS analysis. Relapse, new tumors, or death are considered to have reached the end of the study. For patients who had not experienced disease progression at the end of the study, the last time the patient had no disease progression was used as censoring data.
Overall response rate
Time frame: 1 week after treatment
Overall response rate is the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including complete response (CR) and partial response (PR) cases. Response Evaluation Criteria in Solid Tumors (RECIST 1.1) was used to evaluate the objective response of tumors. Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation is divided into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).
Tumor makers
Time frame: 9 months after treatment
CEA，CA19-9，CA125
5 secondary outcomes
Overall survival
Time frame: 9 months after treatment
Disease control rate
Time frame: 1 week after treatment
Tumor imaging
Time frame: 9 months after treatment
Peripheral blood cytokines
Time frame: 9 months after treatment
ECOG
Time frame: 9 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- 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.
Aiping Le contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoantigen peptide vaccine and Neoantigen-based DC immune preparation in people with Advanced Malignant Solid Tumors, run by The First Affiliated Hospital of Nanchang University 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 15 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: looking for participants now, as of the sponsor's last update on 27 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sujun Li, PhD (8617600699826, 17600699826@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 9 months after treatment). The study lists 3 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 27 Feb 2025.