This is an open, single-arm, investigator-initiated Phase I clinical trial to evaluate the safety, tolerability, and initial efficacy of BST02 injection in patients with locally advanced / metastatic liver cancer. This study includes a dose escalation study and a dose extension study, which will observe the effects of different IL-2 injection doses on the safety and efficacy of BST02.
After signing the informed consent, the subjects will roughly go through two periods: the main study period and the long-term follow-up period. The main study period includes screening period, treatment and safety observation period, and follow-up period
Age 18-75 years old (including the critical value).
Patients with histologically or cytologically confirmed locally advanced / metastatic liver cancer (including hepatocellular carcinoma, intrahepatic bile duct carcinoma, and metastatic liver cancer). Hepatocellular carcinoma (HCC) and cholangiocarcinoma (BCLC) are either stage C or stage B that is not suitable for local treatment/local treatment progression according to Barcelona Clinic Liver Cancer (BCLC). Metastatic liver cancer is not suitable for radical surgical treatment according to the TNM stage of the primary cancer.
For locally advanced liver cancer, guidelines should recommend at least first-line systemic therapy (atrilizumab + bevacizumab, sindilizumab + bevacizumab analogues; Donafenib, Renvastinib, sorafenib; FOLFOX4) after failure (disease progression or intolerance), or as determined by the investigator to be unsuitable, or the patient refused to receive the standard treatment recommended by the guidelines. For metastatic liver cancer, failure (disease progression or intolerance) of at least second-line treatment recommended by guidelines, or inappropriate treatment determined by the investigator, or refusal of standard treatment is required.
At least one operation without radiation or other local treatment within 28 days to remove the tumor lesion with an estimated lesion volume of at least 8 cm^3, excluding necrotic areas, for the preparation of BST02 cells.
Pregnant or lactating women.
Subjects with a history of severe allergy to the experimental drugs including but not limited to cyclophosphamide, fludarabine, IL-2, and TIL injection components.
Patients with past or current hepatic encephalopathy, known to have other central nervous system metastases not effectively controlled by treatment or untreated, except those who have been treated and whose symptoms are stable, and who discontinue glucocorticoid and anticonvulsant therapy ≥4 weeks prior to preconditioning.
There is currently clinically significant ascites, which are defined as ascites with positive signs of ascites in physical examination or requiring intervention treatment (only those who show ascites on imaging without intervention can be included).
BioSyngen Pte Ltd
Lead sponsor
Shenzhen Second People's Hospital
Collaborator