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

Inclusion Criteria:

1. 18-75 years.

2. Histologically or cytologically confirmed advanced solid tumor, with at least onetumor lesion measurable (basis RECIST1.1 standard).

3. HLA typing was HLA-A0201/1101/2402 (containing at least one of the typing, accordingto the central laboratory issued).

4. Paraffin-embedded tumor tissue sections or biopsy tumor tissues within 3 years (fortumors with easy sampling).

5. Before enrollment, systemic standard treatment failure or standard treatmentintolerance, and meet the following tumor requirements : new antigen positive（headand neck tumors, non-small cell lung cancer without driver genes (no EGFR sensitivemutation / ALK fusion positive), esophageal squamous cell carcinoma).

6. Voluntary to participate in clinical research ; the person or legal guardian fullyunderstands and is informed of this study and sign the informed consent; willing tofollow 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;

9. Expected survival time ≥ 6 months.

10. Subjects were willing to study the use of reliable contraceptive methods duringtreatment and within 3 months after the end of treatment, and women of childbearingage.

11. Have adequent organ functions.

12. Before administration of Neo-DCV injection : 1) any chemotherapy, targeted drugs,immune checkpoint inhibitors, other clinical trial research drugs, traditionalChinese medicine with anti-tumor indications and other anti-tumor treatmentsreceived have passed the 4-week elution period, and the toxic and side effectsreturned to grade 1 or lower (except for alopecia, vitiligo and other tolerableevents judged by researchers) ; 2) If undergoing major surgery within 3 weeks, theadverse reactions have returned to grade 1 or lower.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Patients with a history of severe immediate allergies to the cells and any drugsused 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 bythe researchers to be unsuitable for this study.

6. Uncontrolled concomitant diseases or infectious diseases, such as the need forsystemic antibiotics within 2 weeks before enrollment.

7. Suffering from severe liver and kidney function damage (liver, kidney treatment butstill not controllable, biochemical indicators can not meet the inclusion criteriaof NO.11, or can not control the diabetes, pulmonary fibrosis, interstitial lungdisease, acute lung disease, or poor drug control of hypertension ( systolic bloodpressure more than 160mmHg and/or diastolic blood pressure more than 90mmHg), orwith clinical Bed meaning (e.g. activity ) of cardiovascular and cerebrovasculardiseases, such as cerebrovascular accident (6 months before signing informedconsent) unstable angina, myocardial infarction (within 6 months before signinginformed consent), unstable angina, New York Heart Association, or any circumstanceswhich, in the opinion of the researcher, may increase the risk of the subject orinterfere with the results of the test.

8. Subjects planned to receive sugar within 4 weeks before the first Neo-DCV injectionand during the study period due to certain conditions. Corticosteroids (prednisone or the same drug dose less than 10mg/day ) or otherimmunosuppressive agents were excluded.

9. Subjects were scheduled to receive Neo-DCV injection within 4 weeks before the firstadministration and during the study period due to certain conditions.

10. The researchers assessed that the subjects were unable or unwilling to comply withthe requirements of the study protocol.

11. The defects of antigen presentation, antigen recognition and cell killing relatedgenes were detected by sequencing.

12. There was a history of other malignant tumors in the past 5 years, except forcurable basal cell carcinoma, papillary thyroid carcinoma, and uterus.

13. Subjects have any disease or medical condition that may affect the evaluation of thesafety or efficacy of the study drug.