This single-arm, open-label multicenter Phase I/II study will evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of C-CAR031 in adult participants with GPC3+ advanced/recurrent HCC, who have progressed or are intolerant to at least two prior lines of standardized systemic therapy, and lack of other effective treatments.
The participant voluntarily participates in the study, and the individual or their legal guardian signs the informed consent form (ICF).
18 ~ 75 years of age at the time of signing ICF.
Barcelona Clinic Liver Cancer (BCLC) stage C or B (not amenable to surgery/local treatment, includes ablative therapy, interventional and radiation therapy) or stage II-III ( not amenable to surgery/local treatment, includes ablative therapy, interventional and radiation therapy) per China liver cancer staging (CNLC).
Child-Pugh score ≤ 6.
Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO).
Known allergies to lymphodepleting agents, including fludarabine and/or cyclophosphamide.
History of hepatic encephalopathy within past 6 months prior to apheresis or requirement for medications to prevent or control encephalopathy (eg, lactulose, rifaximin, etc infused for purposes of hepatic encephalopathy).
Participants with central nerve system (CNS) diseases such as epilepsy, severe cerebral vascular stenosis, or those who have had a cerebral infarction or other cerebral vascular accidents within 6 months, or other diseases with obvious neurological symptoms (including mental illnesses).
Sequential
Armored and GPC3-targeted autologous CAR T-cell
Biological/VaccineArmored and GPC3-targeted autologous CAR T-cells, single infusion intravenously.
Phase I: Safety and tolerability
• Incidence, correlation and severity of adverse events (AEs).
Phase I: Safety and tolerability
• Incidence, correlation and severity of serious adverse events (SAEs)
Phase I: Safety and tolerability
• Incidence, correlation and severity of adverse events of special interest (AESIs)
Phase I: Safety and tolerability
• Incidence and severity of dose limiting toxicities (DLTs)
Phase I: Pharmacokinetics
• Quantification of CAR transgene DNA copies of C-CAR031 in peripheral blood.
Phase I: Pharmacokinetics
• Time to reach maximum concentration (Tmax) of C-CAR031 in peripheral blood
Phase I: Pharmacokinetics
• Maximum observed concentration (Cmax) of C-CAR031 in peripheral blood
Phase I: Pharmacokinetics
• Area under the curve 28 days after C-CAR031 infusion(AUC0-28d)
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