Evaluating the Safety and Efficacy of BioTTT001 in Patients With Recurrent/Progressive High-grade… (NCT06763965) | Clinical Trial Compass
By InvitationPhase 1/2
Evaluating the Safety and Efficacy of BioTTT001 in Patients With Recurrent/Progressive High-grade Glioma.
China30 participantsStarted 2024-11-26
Plain-language summary
This study is a single-arm, open-label, dose-escalation and dose-expanding Phase Ⅰb/Ⅱ clinical study to evaluate the safety, tolerability, biodistribution characteristics and preliminary efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) in patients with recurrent/progressive high-grade glioma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged 18 years or older, both male and female are eligible;
✓. Patients with high-grade glioma who have recurred/progressed after receiving standard therapy as confirmed by histopathological confirmation meeting the 2021 World Health Organization (WHO) classification criteria for central nervous system tumors;
✓. Suitable for placement of Ommaya sac as judged by the investigator to be eligible for administration;
✓. Estimated survival ≥ 3 months;
✓. Good organ function;
✓. Voluntary participation and ability to sign informed consent form prior to the start of study-related procedures, after explaining the content of the study;
✓. Subjects of childbearing potential and sexually active partners must be willing to use a medically approved and effective method of contraception, such as a double-barrier method of contraception, during treatment and for 6 months after the last dose, and the male agrees not to donate sperm;
Exclusion criteria
✕0. Good compliance, willing and able to follow all research procedures, and cooperate with observation and follow-up.
✕. Received anti-tumor drug therapy such as radiotherapy, chemotherapy, biological therapy, endocrine therapy, targeted therapy and other anti-tumor drugs within 4 weeks before the first dose (excluding immunotherapy, nitrosourea, mitomycin C, oral fluorouracil, small molecule targeted drugs, and traditional Chinese medicines with anti-tumor indications);
✕. Treatment with any other unmarketed investigational drug within 4 weeks prior to the first dose;
✕. Surgical surgery of major organs within 4 weeks prior to the first dose (excluding live puncture) or have had significant trauma, or need to undergo elective surgery during the study;
✕. Those who have a history of cell therapy, gene therapy, and oncolytic virus therapy in the past;
✕. Those who have known or suspected hypersensitivity to the active ingredients of the study drug, excipients, and imaging contrast agents;
✕. Those who have a history of organ transplantation or plan to undergo organ transplantation during the study;
✕. Patients with active infection or uncontrollable infection requiring intravenous systemic therapy, or fever of unknown cause \> 38.5°C during the screening period and before the first dose;