TreatmentNeo-DCV-001NCT06682117
A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor
A study testing DC Vaccine in people with Treatment and Neoantigen, run by Fudan University at 1 site in China.
Trial summary
This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Treatment, Neoantigen, Vaccine
- What is being tested?
- DC Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to 30 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years.
- Histologically or cytologically confirmed advanced solid tumor, with at least one tumor lesion measurable (basis RECIST1.1 standard).
- HLA typing was HLA-A0201/1101/2402 (containing at least one of the typing, according to the central laboratory issued).
- Paraffin-embedded tumor tissue sections or biopsy tumor tissues within 3 years (for tumors with easy sampling).
- Before enrollment, systemic standard treatment failure or standard treatment intolerance, and meet the following tumor requirements : new antigen positive（head and neck tumors, non-small cell lung cancer without driver genes (no EGFR sensitive mutation / ALK fusion positive), esophageal squamous cell carcinoma).
- Voluntary to participate in clinical research ; the person or legal guardian fully understands and is informed of this study and sign the informed consent; willing to follow and be able to complete all test procedures;
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- ECOG score 0-1.
- Have a venous access to meet single collection or venous blood collection;
- Expected survival time ≥ 6 months.
- Subjects were willing to study the use of reliable contraceptive methods during treatment and within 3 months after the end of treatment, and women of childbearing age.
- Have adequent organ functions.
- Before administration of Neo-DCV injection : 1) any chemotherapy, targeted drugs, immune checkpoint inhibitors, other clinical trial research drugs, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments received have passed the 4-week elution period, and the toxic and side effects returned to grade 1 or lower (except for alopecia, vitiligo and other tolerable events judged by researchers) ; 2) If undergoing major surgery within 3 weeks, the adverse reactions have returned to grade 1 or lower.
Who cannot join
- Pregnant or lactating women.
- Patients with a history of severe immediate allergies to the cells and any drugs used in this study.
- Those with a history of organ transplantation.
- Known central nervous system metastasis.
- Any active autoimmune disease or any autoimmune disease that has been determined by the researchers to be unsuitable for this study.
- Uncontrolled concomitant diseases or infectious diseases, such as the need for systemic antibiotics within 2 weeks before enrollment.
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- Suffering from severe liver and kidney function damage (liver, kidney treatment but still not controllable, biochemical indicators can not meet the inclusion criteria of NO.11, or can not control the diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or poor drug control of hypertension ( systolic blood pressure more than 160mmHg and/or diastolic blood pressure more than 90mmHg), or with clinical Bed meaning (e.g. activity ) of cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (6 months before signing informed consent) unstable angina, myocardial infarction (within 6 months before signing informed consent), unstable angina, New York Heart Association, or any circumstances which, in the opinion of the researcher, may increase the risk of the subject or interfere with the results of the test.
- Subjects planned to receive sugar within 4 weeks before the first Neo-DCV injection and during the study period due to certain conditions.
- Corticosteroids (prednisone or the same drug dose less than 10mg/day ) or other immunosuppressive agents were excluded.
- Subjects were scheduled to receive Neo-DCV injection within 4 weeks before the first administration and during the study period due to certain conditions.
- The researchers assessed that the subjects were unable or unwilling to comply with the requirements of the study protocol.
- The defects of antigen presentation, antigen recognition and cell killing related genes were detected by sequencing.
- There was a history of other malignant tumors in the past 5 years, except for curable basal cell carcinoma, papillary thyroid carcinoma, and uterus.
- Subjects have any disease or medical condition that may affect the evaluation of the safety or efficacy of the study drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200020
Dongmei Ji, MD, +86 02164175590-88900, jid09@fudan.edu.cn
About this study
This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.
Read the detailed description
This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors (especially head and neck cancer, non-driver gene sensitive mutation of non-small cell lung cancer). The investigators plan to enroll about 9 patients to explore the dose limited toxicity or recommended dose for future study of Neo-DC vaccine. The study is designed as 3 plus 3 model, and set two dose levels.
- Conditions
- Treatment, Neoantigen, Vaccine, Solid Tumor Cancer
- Being tested
- DC Vaccine
- Keywords
- advanced solid tumors, DC vaccine, neoantigen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC VaccineDrug
Patients will receive Neo-DC vaccine infusion either by dose 1 (1×10^7 cells/time) or dose 2 (5×10^7 cells/time) every 7 days, four cell infusions are one treatment cycle.
The dose limited toxity observation time is within 28 days after the first Neo-DC vaccine infusion.
If the efficacy is evaluated as clinical benefit (CR/PR/SD) or immune unconfirmed progress ( iUPD), treatment cycle can be continued until the completion of four Neo-DC vaccine administrations or disease progression (iCPD by iRECIST) or start new anti-tumor treatment or stop treatment by other reasons.
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Patients will received DC vaccine infusions. Receives: Drug: DC Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
The incidence and severity of adverse events
Measured: Within 28 days after the first Neo-DC vaccine cell infusion
Secondary outcomes (2)
Objective response rate (ORR)
The partial remission (PR) and complete remission rate (CR)
Measured: up 2 years
Dose limited toxicity
Dose limited toxicity within 28 days after the first Neo-DC vaccine cell infusion
Measured: Within 28 days after the first Neo-DC vaccine cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start15 Nov 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm, single center, open label study designed as \"3+3\" model to explore the MTD and DLT of personalized self-DC vaccine targeting neoantigen in treatment of advanced solid tumor.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Dongmei, Fudan University
- Investigators
- Xianghua Wu, M.D, Principal investigator, Fudan UniversityQinghai Ji, M.D, Principal investigator, Fudan UniversityDongmei Ji, M.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682117
- Sponsor's protocol ID
- Neo-DCV-001
- Acronym
- Neo-DCV-001
- Status last verified
- Mar 2026
- First submitted
- 19 Sep 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT06682117
- Acronym / sponsor ID
- Neo-DCV-001 / Neo-DCV-001
- Conditions
- Treatment, Neoantigen, Vaccine, Solid Tumor Cancer
- Keywords
- advanced solid tumors, DC vaccine, neoantigen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Nov 2024 (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.
This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.
Detailed description
This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors (especially head and neck cancer, non-driver gene sensitive mutation of non-small cell lung cancer). The investigators plan to enroll about 9 patients to explore the dose limited toxicity or recommended dose for future study of Neo-DC vaccine. The study is designed as 3 plus 3 model, and set two dose levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm, single center, open label study designed as \"3+3\" model to explore the MTD and DLT of personalized self-DC vaccine targeting neoantigen in treatment of advanced solid tumor.
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: DC VaccinePatients will received DC vaccine infusions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18-75 years.
- Histologically or cytologically confirmed advanced solid tumor, with at least one tumor lesion measurable (basis RECIST1.1 standard).
- HLA typing was HLA-A0201/1101/2402 (containing at least one of the typing, according to the central laboratory issued).
- Paraffin-embedded tumor tissue sections or biopsy tumor tissues within 3 years (for tumors with easy sampling).
- Before enrollment, systemic standard treatment failure or standard treatment intolerance, and meet the following tumor requirements : new antigen positive（head and neck tumors, non-small cell lung cancer without driver genes (no EGFR sensitive mutation / ALK fusion positive), esophageal squamous cell carcinoma).
Key exclusion criteria (14 listed)
- Pregnant or lactating women.
- Patients with a history of severe immediate allergies to the cells and any drugs used in this study.
- Those with a history of organ transplantation.
- Known central nervous system metastasis.
- Any active autoimmune disease or any autoimmune disease that has been determined by the researchers to be unsuitable for this study.
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 |
|---|---|---|
| DC VaccinePatients will receive Neo-DC vaccine infusion either by dose 1 (1×10^7 cells/time) or dose 2 (5×10^7 cells/time) every 7 days, four cell infusions are one treatment cycle. The dose limited toxity observation time is within 28 days after the first Neo-DC vaccine infusion. If the efficacy is evaluated as clinical benefit (CR/PR/SD) or immune unconfirmed progress ( iUPD), treatment cycle can be continued until the completion of four Neo-DC vaccine administrations or disease progression (iCPD by iRECIST) or start new anti-tumor treatment or stop treatment by other reasons. | Drug | treatment arm |
Primary outcome
Adverse events
Time frame: Within 28 days after the first Neo-DC vaccine cell infusion
The incidence and severity of adverse events
2 secondary outcomes
Objective response rate (ORR)
Time frame: up 2 years
Dose limited toxicity
Time frame: Within 28 days after the first Neo-DC vaccine cell infusion
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 2 Apr 2026.
- 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.
Xianghua Wu, M.D principal investigator
Fudan University
Qinghai Ji, M.D principal investigator
Fudan University
Dongmei Ji, M.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DC Vaccine in people with Treatment and Neoantigen, run by Fudan 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 12 inclusion and 14 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 2 Apr 2026. 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 Dongmei Ji, M.D (021-64175590 ext. 83650, jidongmei2000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Within 28 days after the first Neo-DC vaccine cell infusion). 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 2 Apr 2026.