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

Prior treatment

• Subjects received the placement of Carmustine implants within 6 months before the inclusion;
• Subjects receiving immunosuppressants after organ transplantation;
• Within four weeks before the DC vaccinations, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids ( not including inhaled corticosteroid);
• Subjects with unstable pulmonary embolism, deep venous embolism, or other major arterial and venous thromboembolic events that occur within 30 days before the enrollment; receiving ongoing anticoagulant therapy;
• Within the 14 days before enrollment, subjects with active infections or uncontrolled infections that require systemic antibiotic treatment (except for simple urinary tract infections or upper respiratory tract infections);
• Subjects who have received other vaccine therapies or gene-modified cell therapy before enrollment;
• Subjects who participated or are participating in other clinical trials within 4 weeks before enrollment.

Other illness

• Subjects with any other active malignancy;
• Subjects with active HBC, HCV or HIV infection;
• Subjects with grade 2 -3 hypertension or uncontrolled hypertension;
• Subjects with severe cardio- or cerebro- vascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.;
• Subjects with uncontrolled autoimmune diseases such as hemolytic anemia, psoriasis and rheumatoid arthritis, etc.;
• Subjects with severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes;
• Subjects with other conditions that would interfere trial participation at the investigator's discretion;
• Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures; or patients who are unwilling or unable to comply with the research procedures;

Other

• Subjects in pregnancy or breastfeeding, or those who plan to become pregnant during treatment or within 2 months after the end of treatment;
• Subjects with number of the predicted neoantigen peptides less than 5;

• Age from 18 to 75 years (including 18 and 75 years old);
• Newly-diagnosed glioblastoma confirmed by histopathological exams;
• IDH1- and IDH2-wild-type gliomas;
• Extent of resection of enhancing lesions \> 90%;
• Karnofsky Performance Score(KPS) ≥ 60%;
• 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.