RecruitingTreatmentNeoantigenVaccine
A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor
Eligible age
18–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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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.
Sponsor: Fudan University
You may qualify if…
- ✓ 1. 18-75 years.
- ✓ 2. Histologically or cytologically confirmed advanced solid tumor, with at least one tumor lesion measurable (basis RECIST1.1 standard).
- ✓ 3. HLA typing was HLA-A0201/1101/2402 (containing at least one of the typing, according to the central laboratory issued).
- ✓ 4. Paraffin-embedded tumor tissue sections or biopsy tumor tissues within 3 years (for tumors with easy sampling).
- ✓ 5. 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).
- ✓ 6. 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;
- ✓ 7. ECOG score 0-1.
- ✓ 8. Have a venous access to meet single collection or venous blood collection;
You may not qualify if…
- ✕ 1. Pregnant or lactating women.
- ✕ 2. Patients with a history of severe immediate allergies to the cells and any drugs used in this study.
- ✕ 3. Those with a history of organ transplantation.
- ✕ 4. Known central nervous system metastasis.
- ✕ 5. Any active autoimmune disease or any autoimmune disease that has been determined by the researchers to be unsuitable for this study.
- ✕ 6. Uncontrolled concomitant diseases or infectious diseases, such as the need for systemic antibiotics within 2 weeks before enrollment.
- ✕ 7. 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.
- ✕ 8. Subjects planned to receive sugar within 4 weeks before the first Neo-DCV injection and during the study period due to certain conditions.
Source: ClinicalTrials.gov · NCT06682117 · last updated 2026-04-02