Trials / Unknown
UnknownNCT03175705
Adoptive Transfer of Specific HCC Antigens CD8+ T Cells for Treating Patients With Relapsed/Advanced HCC
A Study of Specific HCC Antigens CD8+ T Cells Therapy for Treating Patients With Relapsed/Advanced Hepatocellular Carcinoma (HCC)
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- Beijing YouAn Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HCC antigens-specific CD8+ T lymphocytes | Three different dosing schedules will be evaluated. Three patients will be evaluated on each dosing schedule. The following dose levels will be evaluated: Loading Dose 1: 3x10\^7/m2 Loading Dose 2: 6x10\^7/m2 Loading Dose 3: 9x10\^7/m2 The doses are calculated according to the actual number of GPC3/NY-ESO-1/AFP specific cytotoxic lymphocytes (CTLs) |
| DRUG | IL-2 | IL-2 will be given at a dose of 25000 IU/kg/day for 5-14 days. |
| DRUG | Tegafur | Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks. |
Timeline
- Start date
- 2017-05-01
- Primary completion
- 2018-12-30
- Completion
- 2019-03-30
- First posted
- 2017-06-05
- Last updated
- 2018-01-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03175705. Inclusion in this directory is not an endorsement.