OncoMatch/Clinical Trials/NCT06773481
BC008-1A Injection for Recurrent CNS WHO G4 Glioma
Is NCT06773481 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BC008-1A and BC008-1A for glioma.
Treatment: BC008-1A · BC008-1A — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Disease stage
Required: Stage WHO GRADE 4 (WHO)
Grade: 4 (WHO)
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
Prior therapy
Must have received: standard treatment
disease progression as diagnosed by MRI and evaluated by RANO criteria after standard treatment
Cannot have received: anti-TIGIT therapy
Having been previously exposed to any anti-TIGIT, PD-1, PD-L1 or CTLA-4 drugs
Cannot have received: anti-PD-1 therapy
Having been previously exposed to any anti-TIGIT, PD-1, PD-L1 or CTLA-4 drugs
Cannot have received: anti-PD-L1 therapy
Having been previously exposed to any anti-TIGIT, PD-1, PD-L1 or CTLA-4 drugs
Cannot have received: anti-CTLA-4 therapy
Having been previously exposed to any anti-TIGIT, PD-1, PD-L1 or CTLA-4 drugs
Cannot have received: nitrosourea
Exception: within 42 days before the first receipt of the experimental drug
those who have used nitrosourea drugs within 42 days before the first receipt of the experimental drug cannot be enrolled
Cannot have received: chemotherapy
Exception: within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Subjects who have received chemotherapy ... within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Cannot have received: radiotherapy
Exception: within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Subjects who have received ... radiotherapy ... within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Cannot have received: biotherapy
Exception: within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Subjects who have received ... biotherapy ... within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Cannot have received: endocrine therapy
Exception: within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Subjects who have received ... endocrine therapy ... within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Cannot have received: targeted therapy
Exception: within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Subjects who have received ... targeted therapy ... within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Cannot have received: tumor-treating fields therapy
Exception: within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Subjects who have received ... tumor-treating fields therapy ... within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Cannot have received: immunotherapy
Exception: within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Subjects who have received ... immunotherapy ... within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Cannot have received: anti-tumor Chinese patent medicines
Exception: within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Subjects who have received ... anti-tumor Chinese patent medicines within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter)
Cannot have received: clinical study treatment
Exception: interval from the first use of the study drug is ≤ 28 days
subjects who have received any clinical study treatment and the interval from the first use of the study drug is ≤ 28 days
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (without granulocyte colony-stimulating factor treatment), platelet (PLT) ≥ 100 × 10^9/L, hemoglobin (Hb) ≥ 90 g/L, white blood cell count ≥ 2.0 × 10^9/L, lymphocyte count ≥ 0.5 ×10^9/L
Kidney function
Creatinine (Cr) ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min
Liver function
Total bilirubin (TBIL) ≤ 1.5 × ULN (patients with known Gilbert disease with serum bilirubin level ≤3 × ULN can be included), alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN
Cardiac function
QTc interval < 450 ms for men and < 470 ms for women (Fridericia formula); cardiac function classified as grade I or II according to NYHA classification; no uncontrolled hypertension (systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg), no unstable angina, no recent myocardial infarction (within 6 months), no poorly controlled arrhythmias
Have sufficient hematological function, liver function and renal function, and meet the following laboratory test results before enrollment ... Cardiac function classified as grade III or IV according to the New York Heart Association (NYHA) classification [excluded]; ... QTc interval ≥ 450 ms for men and ≥ 470 ms for women, with the QTc interval calculated by the Fridericia formula [excluded]; ... uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), unstable angina pectoris or myocardial infarction occurring within 6 months before enrollment in the trial, or poorly controlled arrhythmias
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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