The purpose of this Phase I clinical study is to evaluate the safety, preliminary efficacy and pharmacokinetic characteristics of BC008-1A injection in subjects with recurrent CNS WHO grade 4 glioma. This is a randomized and open-label study, with two dose groups set up, and 10 to 20 subjects will be enrolled in each group.
Voluntarily sign the informed consent form;
Recurrent CNS WHO grade 4 glioma: Subjects with CNS WHO grade 4 glioma confirmed by histopathology, who have experienced disease progression as diagnosed by MRI and evaluated by RANO criteria after standard treatment and have no surgical plan;
Male or female aged ≥ 18 years old;
Expected survival time ≥ 12 weeks;
Having been previously exposed to any anti-TIGIT, PD-1, PD-L1 or CTLA-4 drugs;
Having suffered from other malignant tumors and currently requiring treatment (except for cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin that have been adequately treated);
Having an autoimmune disease or a history of autoimmune diseases or related symptoms;
Subjects who cannot undergo MRI (such as those with a pacemaker implanted, non-removable metal dentures, claustrophobia, etc.);
Parallel
BC008-1A
Biological/VaccineBiological: 900 mg BC008-1A will be intravenously injected once every 3 weeks.
BC008-1A
Biological/VaccineBiological: 1200 mg BC008-1A will be intravenously injected once every 3 weeks.
Safety
Assesing the type, frequency, severity, and duration of adverse events.
objective response rate (ORR)
Defined as the proportion of patients who have a complete response (CR) or a partial response (PR) per RANO.
Maximum Plasma Concentration (Cmax)
Immunogenicity
The number and incidence of subjects with anti-drug antibodies (ADA).
Karnofsky performance score(KPS)
To evaluate the change of KPS from baseline.
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Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.
Lead sponsor
Beijing Tiantan Hospital
Collaborator
