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BST02 is an autologous, cryopreserved tumor-infiltrating lymphocyte (TIL) cell therapy developed by Biosyngen for the treatment of liver cancers, including hepatocellular carcinoma (HCC) and cholangiocarcinoma. The therapeutic process involves harvesting lymphocytes from a patient's tumor tissue, expanding them ex vivo, and reinfusing them following lymphodepletion chemotherapy with cyclophosphamide and fludarabine. The regimen includes the administration of interleukin-2 (IL-2) to support the expansion and persistence of the infused TILs within the patient. BST02 is designed to overcome logistical barriers associated with traditional TIL therapies through cryopreservation and aims to utilize lower doses of IL-2 to improve tolerability. It is the first TIL therapy for liver cancer to enter clinical trials globally.
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