A Study on the Novel Oncolytic Virus Combined With PD-1 Inhibitor in the Treatment of Recurrent High-grade Glioma

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Bio-Targeting Therapeutics Technology Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Novel oncolytic virus Ad-TD-nsIL12(BioTTT001)

Treatment groups

15 Participants
are divided into 1 treatment group