Adoptive Transfer of Specific HCC Antigens CD8+ T Cells for Treating Patients With Relapsed/Advanced HCC
NCT ID: NCT03175705
Last Updated: 2018-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
18 participants
INTERVENTIONAL
2017-05-01
2019-03-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous T cell therapy+Tegafur+Interleukin-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.
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)
IL-2
IL-2 will be given at a dose of 25000 IU/kg/day for 5-14 days.
Tegafur
Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
Interventions
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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)
IL-2
IL-2 will be given at a dose of 25000 IU/kg/day for 5-14 days.
Tegafur
Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Beijing YouAn Hospital
OTHER
Responsible Party
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LU JUN
Director of Hepatology and Cancer Biotherapy Ward
Locations
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Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Beijing Youan Ethics[2017]06
Identifier Type: -
Identifier Source: org_study_id
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