NCT03965546

ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer

Clinical Study of ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Advanced Liver Cancer

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of ET 140202 -T cell combined With TAE or Sorafenib in the treatment of liver cancer

Detailed description

The molecular target for ET140202-T cells is HLA-A02 complexed with a HLA-A02-restricted peptide of alpha fetoprotein (AFP), which is expressed on 60-80 percent of hepatocellular carcinoma (HCC). This clinical study evaluates the safety and pharmacokinetics of ET140202-T cells with TAE or Sorafenib in patients with HCC who have no available curative therapeutic options and a poor overall prognosis.

Conditions

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Sorafenib combined with ET140202-T cell	1. Sorafenib starting dose of 400mg b.i.d. a.c. 2. Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct by intravenous (IV) infusion
COMBINATION_PRODUCT	TAE combined with ET140202-T cell	1. Transarterial embolization(TAE) treatment 2. Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct -intravenous (i.v.)
BIOLOGICAL	ET140202-T cell	Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) - expression construct -intravenous (i.v.)

Timeline

• Start date: 2019-05-30
• Primary completion: 2021-06-01
• Completion: 2022-06-01
• First posted: 2019-05-29
• Last updated: 2019-08-08

Locations

1 site across 1 country: China