Glioma Clinical Trials

• The patient and/or guardian must voluntarily sign and date a written informed consent form.

• Age ≥ 18 years and ≤ 75 years at the time of informed consent signing, male or female.

• Confirmed diagnosis of glioma by histopathology and molecular pathology, with recurrent or progressive disease following prior therapy, and no available standard treatment or intolerance to standard treatment.

• Expected survival time of at least 3 months.

• Karnofsky Performance Status (KPS) score ≥ 60.

• Adequate organ and bone marrow function as defined by the following criteria:

‣ Bone marrow reserve: absolute neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 90×10⁹/L, and hemoglobin ≥ 9.0 g/dL (without transfusion or hematopoietic growth factor support within 14 days);

⁃ Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, and international normalized ratio (INR) ≤ 1.5×ULN;

⁃ Hepatic function: total bilirubin (TBIL) ≤ 1.5×ULN, and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; in the presence of liver metastases, ALT and AST ≤ 5×ULN and TBIL ≤ 3×ULN;

⁃ Renal function: creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula);

⁃ Left ventricular ejection fraction (LVEF) ≥ 50%;

⁃ QTcF interval on electrocardiogram \< 450 ms (males) or \< 470 ms (females).

• Subjects of reproductive potential (including male subjects) must agree to avoid pregnancy and use effective contraceptive measures with their partners during the study period and for 6 months after the last dose. A negative serum pregnancy test must be confirmed between screening and prior to the first dose.