OncoMatch/Clinical Trials/NCT05235074
OH2 Oncolytic Viral Therapy in Central Nervous System Tumors
Is NCT05235074 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies OH2 for central nervous system tumors.
Treatment: OH2 — 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.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Must have received: surgery — postoperative
postoperative patients with pathologically confirmed recurrent central nervous system tumors
Cannot have received: chemotherapy
Exception: allowed if >28 days before first use of test drug
The subject has received tumor chemotherapy, targeted therapy or immunotherapy within 28 days before the first use of the test drug.
Cannot have received: targeted therapy
Exception: allowed if >28 days before first use of test drug
The subject has received tumor chemotherapy, targeted therapy or immunotherapy within 28 days before the first use of the test drug.
Cannot have received: immunotherapy
Exception: allowed if >28 days before first use of test drug
The subject has received tumor chemotherapy, targeted therapy or immunotherapy within 28 days before the first use of the test drug.
Cannot have received: radiation therapy
Exception: allowed if >3 months before first use of test drug
Subjects had received radiotherapy to the brain 3 months before their first use of the test drug.
Cannot have received: traditional Chinese medicine
Exception: allowed if >7 days before first use of test drug
The subjects have received traditional Chinese medicine, modern Chinese medicine preparations and antiviral drugs within 7 days before using the test drug for the first time.
Cannot have received: antiviral drugs
Exception: allowed if >7 days before first use of test drug
The subjects have received traditional Chinese medicine, modern Chinese medicine preparations and antiviral drugs within 7 days before using the test drug for the first time.
Lab requirements
Blood counts
WBC≥ 3.0×10^9/L, ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥9.0 g/dL
Kidney function
serum creatinine ≤1.5x ULN, or creatinine clearance ≥50 ml/min (Cockcroft/Gault)
Liver function
total bilirubin ≤ 1.5x ULN; AST and ALT < 2.5x ULN
Cardiac function
INR≤1.5x ULN, APTT≤1.5x ULN; LVEF ≥60%; QTcF ≤450 ms (men), ≤470 ms (women); no NYHA class III/IV CHF, no serious arrhythmia, no recent MI/unstable angina/coronary or peripheral artery bypass/stenting within 6 months, no uncontrolled hypertension (SBP ≥150 mmHg and/or DBP ≥100 mmHg after treatment)
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 ≤ 1.5x ULN; AST and ALT < 2.5x ULN; serum creatinine ≤1.5x ULN, or creatinine clearance ≥50 ml/min (Cockcroft/Gault); Coagulation function: INR≤1.5x ULN, APTT≤1.5x ULN; Cardiovascular disease meets any of the following: a. Congestive heart failure with cardiac function ≥ NYHA class III; b. Serious arrhythmia requiring drug treatment; c. Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass, or stenting occurred within 6 months before the first administration; d. Left ventricular ejection fraction (EF) < 60%; e. QTcF interval > 450 ms in men, > 470 ms in women, or risk factors for torsades de pointes such as clinically significant hypokalemia, family history of long QT syndrome, or family history as judged by the investigator History of arrhythmias (eg, pre-excitation syndrome); f. Uncontrolled hypertension (defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg after standardized antihypertensive drug treatment).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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