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 range18 Years – 80 Years

SexALL

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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;
✕. 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.);

What they're measuring

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

Timeframe: 12 months

Trial details

NCT IDNCT07126990

SponsorXiaorong Wu

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-08-30

View on ClinicalTrials.gov More Glioma trials