Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery

Inclusion Criteria:

1. Age from 18 to 75 years (including 18 and 75 years old);

2. Newly-diagnosed glioblastoma confirmed by histopathological exams;

3. IDH1- and IDH2-wild-type gliomas;

4. Extent of resection of enhancing lesions > 90%;

5. Karnofsky Performance Score(KPS) ≥ 60%;

6. Adequate organ functions:

The absolute value of white blood cells ≥ 2.5×10 9/L; Hemoglobin levels> 100 g/L; Platelet counts > 100×109/L; Levels of Alanine aminotransferase, aspartate aminotransferase <2.5 x ULN; Serum creatinine levels <1.5 x ULN.

Exclusion Criteria:

1. Subjects with any other active malignancy;

2. Subjects received the placement of Carmustine implants within 6 months before theinclusion;

3. Subjects with active HBC, HCV or HIV infection;

4. Subjects with grade 2 -3 hypertension or uncontrolled hypertension;

5. Subjects with severe cardio- or cerebro- vascular diseases such as coronary heartdisease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis,cerebral hemorrhage, etc.;

6. Subjects with uncontrolled autoimmune diseases such as hemolytic anemia, psoriasisand rheumatoid arthritis, etc.;

7. Subjects with severe or uncontrolled psychiatric diseases or condition that couldincrease adverse events or interfere the evaluation of outcomes;

8. Subjects receiving immunosuppressants after organ transplantation;

9. Within four weeks before the DC vaccinations, subjects receiving systemicadministration of steroids with dosage more than 10mg/d prednisone or the equivalentdoses of other steroids ( not including inhaled corticosteroid);

10. Subjects with unstable pulmonary embolism, deep venous embolism, or other majorarterial and venous thromboembolic events that occur within 30 days before theenrollment; receiving ongoing anticoagulant therapy;

11. Subjects in pregnancy or breastfeeding, or those who plan to become pregnant duringtreatment or within 2 months after the end of treatment;

12. Within the 14 days before enrollment, subjects with active infections oruncontrolled infections that require systemic antibiotic treatment (except forsimple urinary tract infections or upper respiratory tract infections);

13. Subjects who have received other vaccine therapies or gene-modified cell therapybefore enrollment;

14. Subjects with number of the predicted neoantigen peptides less than 5;

15. Subjects with other conditions that would interfere trial participation at theinvestigator's discretion;

16. Subjects with medical conditions that affect signing the written informed consent orcomplying with the research procedures; or patients who are unwilling or unable tocomply with the research procedures;

17. Subjects who participated or are participating in other clinical trials within 4weeks before enrollment.