The study is an exploratory clinical trial initiated by an open, single arm researcher to evaluate the safety, tolerability, and preliminary efficacy of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects. This study plans to apply Bayesian Optimal Interval (BOIN) design, with at least 2 and up to 8 DLT assessable subjects in each dose group, who must complete a 28 day DLT assessment period. The study plan includes 2 dose groups: 5x10 \^ 9 and 3x10 \^ 10 BST06 cells
1: The age range is 18-70 years old (including the critical value);
2: HCC patients diagnosed by histopathological or cytological examination, or those who meet the criteria of the American Association for the Study of the Liver (AASLD) or are clinically diagnosed with hepatocellular carcinoma according to the "2022 Guidelines for the Diagnosis and Treatment of Primary Liver Cancer";
3: Tumor tissue pathology immunohistochemistry GPC3 positive;
4: Patients who have undergone at least first-line systemic therapy and have experienced disease progression confirmed by imaging (including but not limited to systemic chemotherapy, targeted therapy, immunotherapy, etc.), have been evaluated by the researchers to have refused other standard treatments at the time of enrollment, or have been determined by the researchers to have difficulty benefiting from treatments recommended by domestic and foreign clinical guidelines or expert consensus.
1: Pregnant or lactating women;
2: Subjects with a history of severe allergies and allergies to experimental drugs including but not limited to cyclophosphamide, fludarabine, BST06 injection components, etc;
3: Past or current presence of hepatic encephalopathy; Known patients with untreated or uncontrolled central nervous system metastases; Except for those who have received treatment and have stable symptoms, and have stopped glucocorticoid and anticonvulsant drug treatment for ≥ 4 weeks before pre-treatment;
4: At present, clinically significant ascites exists, defined as ascites with positive physical examination signs or requiring intervention treatment control (only those with imaging showing ascites without intervention can be included);
Single group
Group A
Biological/Vaccine3.0 × 10 \^ 9 BST06 cells, intravenous infusion，at least 2 subjects enrolled, up to a maximum of 8 subjects enrolled
Group B
Biological/Vaccine3.0 × 10 \^ 10 BST06 cells, intravenous infusion, at least 2 subjects enrolled, up to a maximum of 8 subjects enrolled
Dose-Limiting Toxicity (DLT)
DLT is defined as the following adverse events related to the investigational drug(definitely related, likely related,possibly related) that occur within 28 days after administration of BST08 (using CTCAE 5.0 or CRS grading criteria): (1) hematological toxicity; (2) Grade 3 non hematological toxicity lasting for more than 7 days, or ≥ Grade4 non hematological toxicity, regardless of duration, but excluding the following situations; (3)Cytokine Release Syndrome(CRS)
Maximum ToleratedDose(MTD)
The highest dose of DLT observed in subjects with less than 2/6 (at least 6 subjects in this experimental group received BST08 administration and completed DLT observation)
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BioSyngen Pte Ltd
Lead sponsor
South China Hospital of Shenzhen University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
