A Clinical Study of Oncolytic Virus (OH2) Injection in the Treatment of Patients Undergoing Surgery After Recurrence of Central Nervous System Tumors
In the first phase, it mainly explores the safety, tolerability and preliminary effectiveness of two doses of OH2 injection in the treatment of patients with recurrent central nervous system tumors; to evaluate the biodistribution and virus shedding of OH2 injection administered in the tumor cavity; to evaluate the level of anti-HSV2 antibody in patients when OH2 injection is administered intracavitary to tumor; to determine the phase II recommended dose (RP2D) of OH2 injection in the treatment of recurrent glioblastoma. Phase IIa, to evaluate the preliminary efficacy of OH2 injection in the treatment of patients with recurrent glioblastoma after surgery, and to further evaluate the safety of OH2 in the treatment of relapsed glioblastoma.
• Age ≥ 18 years old, male or female;
• Phase I trials select pathologically confirmed recurrent central nervous system tumors (including but not limited to anaplastic astrocytoma, anaplastic oligoastrocytoma, glioblastoma, gliosarcoma, anaplastic ependymoma, Medulloblastoma, malignant meningioma, melanoma, etc.) postoperative patients; Phase IIa trial selects postoperative patients with pathologically confirmed recurrent glioblastoma
• KPS score ≥60;
• Partial or complete tumor resection, Ommaya reservoir has been placed in the operation area, and drug administration conditions are available;
• As assessed by the investigator, the site of injection of the trial drug is expected to be in the supratentorial area;
• Life expectancy ≥3 months;
• Blood routine: WBC≥ 3.0×10\^9/L, ANC≥1.5×10\^9/L, PLT≥100×10\^9/L, Hb≥9.0 g/dL;
• Liver and kidney function: total bilirubin ≤ 1.5 times the upper limit of the normal value; AST and ALT \< 2.5 times the upper limit of the normal value; serum creatinine ≤1.5 times the upper limit of the normal value, or creatinine clearance ≥50 ml/min (calculated by Cockcroft/Gault formula);
• Coagulation function: INR≤1.5 times the upper limit of the normal value, APTT≤1.5 times the upper limit of the normal value;
⁃ Women of childbearing age had a negative pregnancy test result within 14 days before enrollment. Female subjects and their spouses received effective contraceptives during and within 6 months of treatment;
⁃ The subjects voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.