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New treatment option for Central Nervous System Tumors
Official title OH2 Oncolytic Viral Therapy in Central Nervous System Tumors
ClinicalTrials.gov ID: NCT05235074
What this study is testing
What is OH2 injection?
OH2 injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for central nervous system tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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;
You likely can't join if
- 1.28 days before enrollment, people participated in other clinical trial projects.
- 2.The subject has received tumor chemotherapy, targeted therapy or immunotherapy within 28 days before the first use of the test drug.
- 3.The people have received traditional Chinese medicine, modern Chinese medicine preparations and antiviral drugs within 7 days before using the test...
- 4.people had received radiotherapy to the brain 3 months before their first use of the test drug.
- 5.people with other active extracranial malignancies requiring concomitant therapy.
- 6.people known to be allergic to the test drug or its active ingredients, excipients, and imaging contrast agents.
See the full eligibility 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...
- 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...
- 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 people and their spouses received effective contraceptives during and within 6 months of treatment;
- The people voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
- 1.28 days before enrollment, people participated in other clinical trial projects.
- 2.The subject has received tumor chemotherapy, targeted therapy or immunotherapy within 28 days before the first use of the test drug.
- 3.The people have received traditional Chinese medicine, modern Chinese medicine preparations and antiviral drugs within 7 days before using the test drug for the first time.
- 4.people had received radiotherapy to the brain 3 months before their first use of the test drug.
- 5.people with other active extracranial malignancies requiring concomitant therapy.
- 6.people known to be allergic to the test drug or its active ingredients, excipients, and imaging contrast agents.
- 7.people who are going to undergo or have received tissue/organ transplantation in the past.
- 8.The subject has active infection or unexplained fever \>38.5℃ during the screening period and before the first dose.
- 9.people with active pulmonary tuberculosis (TB) who are receiving anti-tuberculosis treatment or who have received anti-tuberculosis treatment within 1 year before screening.
- 10.Anti-HIV(+) or anti-HCV(+) or specific antibody (TPHA) positive or active hepatitis B (hepatitis B people who meet the following criteria are also eligible for inclusion: a) HBV viral load before the first dose The...
- 11.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...
- 12.people with active autoimmune disease or a history of autoimmune disease but may relapse, but people with the following diseases are not excluded and can be further screened: a. Type 1 diabetes; b. Hypothyroidism (if...
- 13.people with unstable mental illness, alcohol, drug or substance abuse. 14. Female people who are pregnant or breastfeeding, or who are expected to become pregnant during the trial period (from the screening visit...
- 15\. The adverse reactions of previous anti-tumor therapy have not recovered to (CTCAE 5.0) grade 1 (except for alopecia).
- 16\. The investigator determines that he has a serious uncontrollable disease, or there are other conditions that may affect the acceptance of the treatment in this study, and are considered unsuitable to participate in...
- 17\. Other investigators deem it unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.