Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC

• Status: Unknown status
• Trial end date: 2019-03-30
• Target enrollment: 0
• Participant gender: All

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 special immune system cells called iNKT cells, a new experimental treatment.

The purpose of this study is to find the biggest dose of iNKT cells that is safe and tolerance, to see how long they last in the body, to learn the immunoresponse in the body, to learn the side effects are and to see if the iNKT cells will help people with relapsed/advanced hepatocellular carcinoma (HCC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing YouAn Hospital
• Treatments: Interleukin-2; Tegafur

Criteria

Inclusion Criteria:

• Age 18-80 years.

• Patients with hepatocellular carcinoma (BCLC, stage C) proved by histopathology or proved by CT or MRI imaging system, 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.

• iNKT>10/mL in peripheral blood mononuclear cell (PBMC).

• 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.