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)
1 other identifier
interventional
18
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hepatocellular-carcinoma
Started May 2017
Shorter than P25 for phase_1 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 24, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedJanuary 18, 2018
January 1, 2018
1.7 years
May 24, 2017
January 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety]
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.
4 weeks
Secondary Outcomes (1)
Biological activity of infused T cells
4 weeks
Other Outcomes (2)
Progress Free Survival (PFS)
12 weeks or up to death
Disease Control Rate (DCR)
12 weeks or up to death
Study Arms (1)
Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)
EXPERIMENTALAutologous 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.
Interventions
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)
IL-2 will be given at a dose of 25000 IU/kg/day for 5-14 days.
Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100069, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Hepatology and Cancer Biotherapy Ward
Study Record Dates
First Submitted
May 24, 2017
First Posted
June 5, 2017
Study Start
May 1, 2017
Primary Completion
December 30, 2018
Study Completion
March 30, 2019
Last Updated
January 18, 2018
Record last verified: 2018-01