OH2 Oncolytic Viral Therapy in Central Nervous System Tumors (NCT05235074) | Clinical Trial Compass
CompletedPhase 1/2
OH2 Oncolytic Viral Therapy in Central Nervous System Tumors
China40 participantsStarted 2021-11-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used an oncolytic virus called OH2 injected directly into brain or central nervous system tumors — given how experimental that approach is, what serious side effects or dose-limiting toxicities were reported, and how would those risks compare to my current treatment options?
2Since this was a Phase 1/2 trial focused on finding the maximum tolerated dose, does that mean the researchers were still figuring out safety rather than proving the treatment works — and what does that mean for how much we actually know about whether it helped patients?
3The trial is now completed — do you know if the results have been published or shared anywhere, and would those findings change how you'd think about this approach for my specific type of CNS tumor?
4Oncolytic viral therapy is very different from standard chemotherapy or radiation — is this the kind of treatment that would typically come after trying standard options first, or is it something worth considering alongside them for my situation?
5Because the drug was delivered directly to the central nervous system, would participating in a future study like this require specialized neurosurgery, and is that something my care team here could support?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MTD (Maximum Tolerance dose)
Timeframe: 2 years
2
DLTs (Dose Limiting Toxicity)
Timeframe: 3 weeks from the first administration
3
Incidence of AE (Adverse Event) and SAE (Serious Adverse Event)
. 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);
Exclusion criteria
.28 days before enrollment, subjects participated in other clinical trial projects.
.The subject has received tumor chemotherapy, targeted therapy or immunotherapy within 28 days before the first use of the 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.
.Subjects had received radiotherapy to the brain 3 months before their first use of the test drug.
.Subjects with other active extracranial malignancies requiring concomitant therapy.
.Subjects known to be allergic to the test drug or its active ingredients, excipients, and imaging contrast agents.
.Subjects who are going to undergo or have received tissue/organ transplantation in the past.
.The subject has active infection or unexplained fever \>38.5℃ during the screening period and before the first dose.