Clinical Study of a Novel Oncolytic Virus Ad-TD-nsIL12 in the Treatment of Primary High-grade Glioma (NCT07126990) | Clinical Trial Compass
By InvitationPhase 1/2
Clinical Study of a Novel Oncolytic Virus Ad-TD-nsIL12 in the Treatment of Primary High-grade Glioma
China40 participantsStarted 2025-02-12
Plain-language summary
Clinical study of a novel oncolytic virus Ad-TD-nsIL12 in the treatment of primary high-grade glioma
Who can participate
Age range
18 Years – 80 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 18-80 years old (including cut-off value), both male and female;
. Glioma that meets the 2021 edition of the World Health Organization (WHO) classification criteria for central nervous system tumors and has not undergone any anti-tumor treatment;
. The lesion is located in the non-functional area (Experiment 1) / the lesion is located in the functional area and thalamus (Experiment 2);
. Have an intracranial measurable target lesion (refer to the iRANO standard);
. Karnofsky Performance Score (KPS) ≥ 60 points;
. Expected survival ≥ 3 months;
. Good organ function;
. Subjects of childbearing potential and their partners who are sexually active must be willing to use a medically approved effective method of contraception, such as double-barrier contraception, during treatment and within 6 months after the last dose, and men agree not to donate sperm;
Exclusion criteria
. Received any anti-tumor therapy (referring to the tumor to be observed) in the past;
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
To evaluate the effectiveness of new oncolytic adenovirus Ad-TD-nsIL12 in the treatment of patients with non-functional zones, functional zones and thalamic primary HGG
. Underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose, or required to undergo elective surgery during the study;
. Known or suspected allergy to the active ingredients, excipients and contrast agents of the study drug;
. Those with a history of organ transplantation or planned organ transplantation during the study;
. Those with active infection or uncontrollable infection requiring intravenous systemic treatment, or unexplained fever \>38.5°C during screening and before the first dose;
. Severe coagulation disorders or other obvious evidence of bleeding risk; History of gastrointestinal bleeding; Any other ≥ CTCAE grade 2 bleeding event in the past 6 months;
. Subjects who have received systemic steroid drugs (\> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days before the first dose; The following are excluded: treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylactic treatment (e.g., to prevent contrast allergy);
. Adverse reactions of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade ≤ grade 1 (except for toxicities judged by the investigator to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, etc.);