drugset / Trial / NCT03175705

Adoptive Transfer of Specific HCC Antigens CD8+ T Cells for Treating Patients With Relapsed/Advanced HCC

NCT03175705

Phase 1 Unknown 18 enrolled Beijing YouAn Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or the patients cannot receive standard treatment under current conditions. This research study uses specific HCC antigens CD8+ T cells, a new experimental treatment. The purpose of this study is to evaluate the safety and tolerance as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with human leukocyte antigen (HLA)-peptide multimers and specific for Glypican (GPC)-3 /New York Esophageal Squamous-1 (NY-ESO-1) /alpha-fetoprotein (AFP) antigens and cultured in vitro, to patients suffering from relapsed/advanced hepatocellular carcinoma (HCC).

Timeline

Start
2017-05-01
Primary completion
2018-12-30
Completion
2019-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject HCC antigens-specific CD8+ T lymphocytes Cell therapy 3e+07 unknown
Subject HCC antigens-specific CD8+ T lymphocytes Cell therapy 6e+07 unknown
Subject HCC antigens-specific CD8+ T lymphocytes Cell therapy 9e+07 unknown
Background S-1 Small molecule 40 mg
Background S-1 Small molecule 60 mg
Background aldesleukin Protein / enzyme biologic 25000 iu/kg