A Clinical Study of Oncolytic Virus (OH2) Injection in the Treatment of Patients Undergoing Surgery After Recurrence of Central Nervous System Tumors

Who is this study for? Patients undergoing surgery after recurrence of central nervous system tumors
What treatments are being studied? OH2
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Wenbin Li
neure55@126.com
15301377998
Time Frame
Start Date: 2021-11-16
Estimated Completion Date: 2026-06-16
Participants
Target number of participants: 28
Treatments
Experimental: Dose escalation and dose expansion
The dose-escalating phase of the phase I trial of OH2 injection is divided into two dose groups (10\^6 CCID50/mL and 10\^7 CCID50/mL).It will be administered by Ommaya reservoir injection, and the total amount of each dose in each dose group should not exceed 2ml according to the size of the tumor cavity.
Sponsors
Leads: Binhui Biopharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov