Hepatocellular Carcinoma Clinical Trial
Official title:
Phase 1, Open-label, Two Routes IV and Intra-hepatic Artery Dose-escalation Clinical Study to Evaluate the Safety and Efficacy of ET1402L1-CAR T- Cells in AFP Expressing Hepatocellular Carcinoma (HCC)
Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET1402L1-CART-cells in patients with AFP+ HCC
The molecular target for ET1402L1-CART is alpha fetoprotein (AFP), which is expressed on
60-80 percent of hepatocellular carcinoma (HCC). ET1402L1-CART is a second generation
(CD28/CD3ΞΆ) chimeric antigen receptor (CAR) engineered with a human single-chain variable
antibody fragments (scFv) against the anti-HLA-A02/AFP complex. This clinical study evaluates
the safety and pharmacokinetics of ET1402L1-CART-cells in patients with HCC who have no
available curative therapeutic options and a poor overall prognosis.
Patients with lesion(s) localized in liver will be enrolled in the IA arm, with the
ET1402L1-CART-cells administered via intrahepatic artery catheter. Patients with extrahepatic
metastasis will be enrolled in the IV arm, with the ET1402L1-CART-cells administered through
intravenous infusion.
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