Actively Recruiting
A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor
Led by Fudan University · Updated on 2026-04-02
9
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.
CONDITIONS
Official Title
A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histologically or cytologically confirmed advanced solid tumor with at least one measurable lesion based on RECIST1.1
- HLA typing includes HLA-A0201, HLA-A1101, or HLA-A2402 as confirmed by central laboratory
- Availability of paraffin-embedded tumor tissue or biopsy samples within 3 years for tumors easy to sample
- Failure or intolerance to standard systemic treatments before enrollment, with tumor types including neoantigen-positive head and neck tumors, non-driver gene mutated non-small cell lung cancer, or esophageal squamous cell carcinoma
- Voluntary participation with signed informed consent and ability to complete all study procedures
- ECOG performance status score of 0 or 1
- Having venous access suitable for blood collection
- Expected survival time of at least 6 months
- Willingness to use reliable contraception during treatment and for 3 months after treatment if of childbearing potential
- Adequate organ function
- At least 4 weeks since last chemotherapy, targeted therapy, immune checkpoint inhibitors, other anti-tumor treatments, or clinical trial drugs, with toxicities resolved to grade 1 or lower except tolerated events
- At least 3 weeks since major surgery with adverse reactions resolved to grade 1 or lower
You will not qualify if you...
- Pregnant or breastfeeding women
- History of severe immediate allergies to cells or drugs used in the study
- History of organ transplantation
- Known central nervous system metastasis
- Active autoimmune disease or autoimmune disease deemed unsuitable by researchers
- Uncontrolled infections or diseases requiring systemic antibiotics within 2 weeks before enrollment
- Severe liver or kidney damage, uncontrolled diabetes, pulmonary fibrosis, interstitial or acute lung disease, poorly controlled hypertension, or significant cardiovascular/cerebrovascular disease
- Planned use of sugar treatments within 4 weeks before or during the study
- Use of corticosteroids above prednisone 10mg/day or other immunosuppressive agents
- Planned Neo-DC vaccine injections within 4 weeks before or during the study
- Inability or unwillingness to comply with the study protocol
- Genetic defects affecting antigen presentation or killing detected by sequencing
- History of other malignant tumors within 5 years except certain curable cancers
- Any medical condition that may affect safety or study evaluation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200020
Actively Recruiting
Research Team
D
Dongmei Ji, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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