A Dose-escalation, Single-arm, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 Targeted Chimeric Antigen Receptor T Cell Therapy in Patients With GPC3 Positive Advanced Hepatocellular Carcinoma Who Have Failed Standard Therapy
To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 (GPC3) Targeted Chimeric Antigen Receptor T cell therapy in Patients with GPC3 Positive Advanced Hepatocellular Carcinoma who Have Failed Standard Therapy
• To be eligible, subjects must meet all of the following criteria:
‣ Male or female adults ≥19 years old at the time of written informed consent
⁃ Patients with histologically or cytologically diagnosed unresectable HCC refractory to first- or second-line standard therapy\* with no other standard therapy available
‣ \* Including, but not limited to atezolizumab plus bevacizumab combination therapy and tyrosine kinase inhibitors (e.g., sorafenib, lenvatinib).
⁃ Confirmed GPC3 positivity by IHC based on a liver tissue sample
⁃ At least 1 measurable lesion based on mRECIST v1.1
⁃ Child-Pugh score Class A or Class B(7)
⁃ Life expectancy ≥3 months based on the judgment of the investigator
⁃ ECOG PS 0 or 1
⁃ Patients who have adequate bone marrow, liver, and kidney functions at the time of screening:
‣ WBC ≥ 2,000 /μL ANC ≥ 1,000 /μL Platelet ≥ 80,000 /μL Hemoglobin ≥ 9.0 g/dL Albumin ≥ 2.8 g/dL AST and ALT ≤ 5ⅹULN Total bilirubin ≤ 2 x ULN Serum creatinine ≤1.5 x ULN Creatinine clearance (CrCl) ≥ 30 mL/min PT(INR) ≤1.5 x ULN
⁃ Negative serum pregnancy test in women of childbearing potential
‣ Women of childbearing potential or men who do not plan a pregnancy during the study period and who agree to use clinically adequate methods of contraception as follows:
∙ \* Hormone contraceptives (subcutaneous implants, injections, oral contraceptives, etc.), intrauterine device (IUD) (or intra uterine system \[IUS\]), subject's or partner's surgical sterilization (vasectomy, tubal ligation, etc.), double barrier methods (combined use of barrier methods such as combined use of cervical cap or diaphragm plus male condom)
‣ Written informed consent to voluntary study participation