NCT03349255

Clinical Study of ET1402L1-CAR T Cells in AFP Expressing Hepatocellular Carcinoma

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Aeon Therapeutics (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET1402L1-CART-cells in patients with AFP+ HCC

Detailed description

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/CD3ζ) 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.

Conditions

• Hepatocellular Carcinoma
• Liver Cancer
• Liver Neoplasms
• Metastatic Liver Cancer

Interventions

Type	Name	Description
BIOLOGICAL	autologous ET1402L1-CART cells	Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1)-CAR expression construct

Timeline

• Start date: 2017-10-06
• Primary completion: 2019-01-10
• Completion: 2019-01-10
• First posted: 2017-11-21
• Last updated: 2019-07-01

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study