A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor

Inclusion Criteria19

• 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;
• 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.
• 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.