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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized self-DC vaccine that targets neo-antigens (Neo-DC vaccine) for treating advanced solid tumors, including head and neck cancer and certain types of non-small cell lung cancer without driver gene mutations. This study aims to explore the dose-limiting toxicity and identify the recommended dose for future Neo-DC vaccine research. About 9 patients will be enrolled, following a 3 plus 3 dose escalation design with two dose levels. Participants will receive infusions of the Neo-DC vaccine at either a lower dose (1 x 10^7 cells per infusion) or a higher dose (5 x 10^7 cells per infusion) given every 7 days. Four infusions make up one treatment cycle. If clinical benefit or certain immune responses are observed, treatment cycles may continue until four administrations are completed, disease progression occurs, new anti-tumor treatments begin, or treatment is stopped for other reasons. Dose-limiting toxicity is monitored within 28 days after the first infusion. During the study, participants will be monitored for adverse events within 28 days of the first vaccine infusion. Researchers will also assess the objective response rate over up to 2 years and observe dose-limiting toxicities in the same 28-day window. Participants must complete all study procedures, including blood collections and tumor assessments based on RECIST 1.1 standards. The total participation duration varies depending on treatment continuation and disease status.
CONDITIONS
Brief 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
- HLA typing includes HLA-A0201, HLA-A1101, or HLA-A2402
- Availability of paraffin-embedded tumor tissue sections or biopsy tissue within 3 years
- Prior failure or intolerance of standard systemic treatments, with tumors positive for new antigens (head and neck tumors, non-driver gene mutated non-small cell lung cancer, 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
- Suitable venous access for blood collection
- Expected survival time of at least 6 months
- Willingness to use reliable contraception during treatment and for 3 months after
- Adequate organ function
- Completion of required washout periods from prior treatments and recovery from toxic side effects before Neo-DC vaccine administration
You will not qualify if you...
- Pregnant or lactating women
- History of severe allergies to cells or drugs used in this study
- History of organ transplantation
- Known central nervous system metastasis
- Active autoimmune diseases or autoimmune diseases unsuitable for this study
- Uncontrolled infections or concomitant diseases requiring recent systemic antibiotics
- Severe liver, kidney, cardiovascular, pulmonary, or other uncontrolled medical conditions
- Use of corticosteroids or immunosuppressive agents exceeding allowed doses
- Scheduled to receive Neo-DC vaccine within 4 weeks before first administration or during study without meeting criteria
- Inability or unwillingness to comply with study protocol
- Genetic defects affecting antigen presentation or cell killing
- History of other malignant tumors within 5 years except certain curable cancers
- Any condition that may affect safety or efficacy evaluation of the study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 7-day cycles until completion of four infusions or disease progression
Participants receive personalized Neo-DC vaccine infusions by dose every 7 days. Four infusions make up one treatment cycle. Treatment continues until completion of four vaccine administrations, disease progression, start of new anti-tumor treatment, or other reasons for stopping.
Weekly visits for vaccine infusion during each cycle
Duration - Up to 2 years
Participants are monitored for safety and response after treatment completion, including observation for adverse events and assessment of clinical benefit.
Regular visits to assess response and monitor safety
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
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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