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

Capital Medical University

Status and phase: Unknown; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Biological: HCC antigens-specific CD8+ T lymphocytes; Drug: IL-2; Drug: Tegafur

Study type: Interventional

Funder types: Other

Identifiers

NCT03175705

Beijing Youan Ethics[2017]06

Details and patient eligibility

About

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).

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)

Experimental group

Description:

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.

Treatment:

Biological: HCC antigens-specific CD8+ T lymphocytes

Drug: Tegafur

Drug: IL-2