XS005 Injection Combined With Stupp Regimen for Adjuvant Chemotherapy in Subjects With Primary Glioblastoma(GBM)

Inclusion Criteria:

1. Age between 18 and 70 years old (including the threshold), both male and female;

2. Expected survival ≥6 months;

3. Karnofsky performance status(KPS) score ≥60 before treatment;

4. The level of organ and bone marrow function must meet the following requirements:

• Bone marrow: Absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90g/L, and no platelet or red blood cell transfusionwithin 14 days prior to first administration. And did not receive bloodtransfusion or biological response regulators (such as granulocyte growthfactor, erythrocyte growth factor, interleukin-11, etc.) within 14 days beforethe first administration;

• Liver function: No history of cirrhosis (Child-Pugh grade B, C). Serum totalbilirubin (TBIL) ≤1.5× upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN;

• Renal function: serum creatinine ≤1.5×ULN, or creatinine clearance ≥50ml/min (Cockcroft-Gault formula); Qualitative urine protein ≤1+; If the qualitativeurine protein is ≥2+, it is necessary to conduct a quantitative urine proteintest for 24 hours. According to the examination results, the researchers madethe admission judgment.

• Coagulation function: prothrombin time (PT) ≤1.5×ULN; Internationalstandardized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN (except those receiving therapeutic anticoagulants);

5. The subjects (including male subjects) have no pregnancy plan and voluntarily takeeffective contraceptive measures during the screening period and from the beginningof the study administration to the last dose of the study drug within 6 months afterthe study drug is administered, and have no sperm or egg donation plans, in whichthe study period should voluntarily take effective contraceptive measures;

6. Able to understand the procedures and methods of this study, willing to signinformed consent and strictly follow the clinical study protocol to complete thisstudy.

Exclusion Criteria:

1. Patients who received other anti-tumor drugs (including chemotherapy, targeted drugsother than bevacizumab, immunotherapy, Chinese medicine anti-tumor therapy, etc.)except for patients who received concurrent radiotherapy and chemotherapy for GBMafter surgery (TMZ dosage ≤75mg/m2, radiotherapy dose limited to 50-60Gy);

2. Previous or current malignant tumors of other types, except for the following cases:basal cell carcinoma of the skin, superficial bladder cancer, squamous cellcarcinoma of the skin or cervical cancer in situ;

3. The presence of any contraindications to MRI, such as: use of a pacemaker, infusionpump, or allergy to MRI contrast agents;

4. Receive live attenuated vaccine or vaccine within 4 weeks prior to the first studydrug treatment or plan to receive live vaccine during the study period;

5. Subjects with active or pre-existing autoimmune diseases that are likely to recur,or patients at high risk (such as those who have received an organ transplant andrequire immunosuppressive therapy).