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

Phase 1

• Conditions: Hepatocellular Carcinoma
• Interventions: Biological: HCC antigens-specific CD8+ T lymphocytes; Drug: IL-2; Drug: Tegafur

• Registration Number: NCT03175705
• Lead Sponsor: Beijing YouAn Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-18
• Primary Completion: 2018-12-30
• Study Completion: 2019-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age 18-80 years
• Patients with relapsed/advanced HCC (BCLC, stage C) proved by histopathology or proved by CT or MRI imaging system, proven GPC3/NY-ESO-1/AFP(+), relapsed after previous therapy and no effective therapies known at this time.
• Life expectancy of ≥ 12 weeks.
• WBC>3.5×10^9/L, LYMPH> 0.8×10^9/L, Hb>85g/L, PLT>50×10^9/L, Cre<1.5×the upper limit of normal value.
• Able to understand and sign the informed consent.

Exclusion Criteria

• Any uncontrolled systematic disease: hypertension, heart disease, and et al.;
• Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors;
• Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment;
• Unstable immune systematic diseases or Infectious diseases;
• Combined with AIDS or syphilis;
• Patients with history of stem cell or organ transplantation;
• Patients with allergic history to related drugs and immunotherapy;
• Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage;
• Pregnant or lactating subjects;
• Unsuitable subjects considered by clinicians.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)	Tegafur	Autologous in vitro expanded HCC antigens-specific CD8+ T lymphocytes in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with relapsed/advanced HCC.
Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)	HCC antigens-specific CD8+ T lymphocytes	Autologous in vitro expanded HCC antigens-specific CD8+ T lymphocytes in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with relapsed/advanced HCC.
Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)	IL-2	Autologous in vitro expanded HCC antigens-specific CD8+ T lymphocytes in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with relapsed/advanced HCC.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety]	4 weeks	Defined as signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.

Secondary Outcome Measures

Name	Time	Method
Biological activity of infused T cells	4 weeks	To assess the biological activity of infused in vitro expanded and sorted HCC antigens-specific T cells.

Trial Locations

Locations (1)

Beijing Youan Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China