A single-arm clinical study on the efficacy and safety of the novel oncolytic virus Ad-TD-nsIL12 combined with PD-1 inhibitors in the treatment of recurrent high-grade glioma
Willing and able to provide written informed consent for the study
Be at least 18 years old from the date of signing the informed consent form
Patients with high-grade glioma (HGG) who have recurred/progressed after receiving standard treatment and confirmed to meet the 2021 edition of the World Health Organization (WHO) classification criteria for central nervous system tumors by histopathology
According to the RANO 2.0 evaluation criteria, there is at least one measurable lesion, that is, the maximum vertical diameter of the lesion is ≥ 10mm
Received treatment with any other unmarketed investigational drug within 4 weeks prior to the first dose
Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose, or need to undergo elective surgery during the study
Those who have a history of cell therapy, gene therapy, or oncolytic virus treatment
Patients who are unable to undergo magnetic resonance imaging (MRI) or single-photon emission computed tomography (SPECT) due to obesity or the presence of certain metals in the body, especially pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates
Single group
Novel oncolytic virus Ad-TD-nsIL12（BioTTT001）
Biological/VaccineInject Ad-TD-nsIL12 into the tumor via Ommaya reservoir, administering on days 1, 4, and 7, and infuse a PD-1 inhibitor on day 9.Ad-TD-nsIL12 is injected every 21 days (± 3 days) as appropriate in subsequent cycles. On the 7th day (±3 days) after oncolytic virus administration each cycle, a PD-1 inhibitor is given, or until disease progression or the occurrence of intolerable toxicity.
Evaluation of the efficacy of the novel oncolytic virus Ad-TD-nsIL12 combined with PD-1 inhibitors in treating recurrent HGG patients
the time from the first oncolytic virus treatment to death from any cause; median OS was assessed
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This trial is not recruiting at the moment. You can still explore other options:
