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New treatment option for Glioblastoma (GBM)
Official title Clinical Study of Oncolytic Virus in Glioblastoma
ClinicalTrials.gov ID: NCT07145047
What this study is testing
What is oncolytic virus?
oncolytic virus is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for glioblastoma (gbm).
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
- This clinical trial aims to evaluate whether an oncolytic viral agent can treat recurrent glioblastoma. It will also assess the safety and tolerability of the oncolytic viral agent.
- 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 to 70
You may be able to join if
- Patients with recurrent glioblastoma, for whom the standard methods of treatment are considered ineffective by the medical commission.
- Histologically confirmed recurrent glioblastoma.
- Magnetic resonance imaging (MRI) showed that the maximum diameter of recurrent lesions is greater than 1.0 cm.
- Before inclusion of patients in the study, at least one of the following types of therapy was previously performed: 4.1 Time from the last...
- Age \>=18 years, \<=70 years.
You likely can't join if
- Incompatibility of patients with the inclusion criteria mentioned above.
- Participated in other drug clinical trials within 4 weeks
- Preoperative bleeding susceptibility or use of anticoagulants or any medication that may increase the risk of bleeding.
- Patients with extracranial metastases.
- Have poorly controlled clinical diseases, such as liver aminotransferase (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) or...
- Female people: during pregnancy or lactation.
See the full eligibility criteria
- Patients with recurrent glioblastoma, for whom the standard methods of treatment are considered ineffective by the medical commission.
- Histologically confirmed recurrent glioblastoma.
- Magnetic resonance imaging (MRI) showed that the maximum diameter of recurrent lesions is greater than 1.0 cm.
- Before inclusion of patients in the study, at least one of the following types of therapy was previously performed: 4.1 Time from the last radiotherapy/surgery is more than 28 days; 4.2 people maintained stable or...
- Age \>=18 years, \<=70 years.
- Hematological indicators, kidney and liver function are normal.
- The people must agree to the use of an acceptable contraceptive method throughout the study, from the time informed consent is provided to 180 days after receiving treatment.
- Patient's ability to perform the study procedure and provide written informed consent in accordance with the GCP and local laws.
- Incompatibility of patients with the inclusion criteria mentioned above.
- Participated in other drug clinical trials within 4 weeks
- Preoperative bleeding susceptibility or use of anticoagulants or any medication that may increase the risk of bleeding.
- Patients with extracranial metastases.
- Have poorly controlled clinical diseases, such as liver aminotransferase (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) or total bilirubin \> 2 times the upper normal limit.
- Female people: during pregnancy or lactation.
- Uncontrolled active infection, unstable or severe concomitant disease of infection. Patients with immunodeficiency, autoimmune diseases, active HBV infection, HCV infection, or active HIV infection.
- Patients with a history of psychotropic substance abuse who are unable to quit or with mental disorders.
- people had any active autoimmune disease or a history of autoimmune disease.
- Has a history of antiviral drug use within 1 week.
- people are receiving immunosuppressive therapy, or concurrent chemotherapy, or radiation, or biotherapy.
- There are prohibited items for MRI, such as: pacemakers, epicardial pacemaker wires, infusion pumps, surgical and/or aneurysm clips, shrapnel, metal prostheses, potentially magnetic implants, metal objects in the eye...
- History of substance abuse or known medical, or psychological, or social conditions, such as alcohol or drug abuse.
- Allergic, hypersensitive or intolerant to study oncolytic viruses (including any excipients).
- Vaccination within 30 days prior to administration.
- Patients who have received gene transfer therapy or treated with any type of oncolytic virus.
- History of encephalitis, or multiple sclerosis, or other central nervous system (CNS) infections, or primary CNS disease.
- Male or female patients who refused contraception during the study period and for 6 months after dosing.
- In the investigator's judgment, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's ability to complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Mianyang, Sichuan, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mianyang, Sichuan, 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.