Back to resultsAdoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
iNKT cells
IL-2
Tegafur
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility 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.
Sites / Locations
- Beijing Youan Hospital,Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous iNKT Cells + Tegafur +Interleukin-2(IL-2)
Arm Description
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Biological activity of infused iNKT cells
To assess the biological activity of infused in vitro expanded autologous iNKT cells in conjunction with IL-2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03175679
Brief Title
Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC
Official Title
A Study of Adoptive Invariant Nature Killer T Cell Therapy for Relapsed/Advanced Hepatocellular Carcinoma (HCC)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
March 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing YouAn Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Three planned infusions for 18 patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autologous iNKT Cells + Tegafur +Interleukin-2(IL-2)
Arm Type
Experimental
Arm Description
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
Intervention Type
Biological
Intervention Name(s)
iNKT cells
Intervention Description
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 iNKT cells.
Intervention Type
Drug
Intervention Name(s)
IL-2
Other Intervention Name(s)
Human recombinated Interleukin-2
Intervention Description
IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Intervention Type
Drug
Intervention Name(s)
Tegafur
Other Intervention Name(s)
Gimeracil and Oteracil Potassium Capsules
Intervention Description
Tegafur will be given at a dose of 40~60 mg bis in die (BID) 2 weeks.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety]
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Biological activity of infused iNKT cells
Description
To assess the biological activity of infused in vitro expanded autologous iNKT cells in conjunction with IL-2.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Progression-Free Survival (PFS)
Description
PFS is the time that passes from the date that patient enrolled in the clinical trial and the date on which HCC progresses or the date on which the patient dies. HCC progression was evaluated by imaging according to the irRC standard.
Time Frame
12 weeks or up to death
Title
Disease Control Rate (DCR)
Description
DCR is the proportion of patients who had a response rate including complete remission (CR), partial remission (PR) and disease stabilization (SD) evaluated by imaging according to the irRC standard.
Time Frame
12 weeks or up to death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Lu, Director
Phone
86-13661381489
Email
lujun98@ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xuli Bao, Clinician
Phone
86-13161935299
Email
bxli2001@163.com
Facility Information:
Facility Name
Beijing Youan Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuli Bao, Clinician
Phone
86-13161935299
Email
bxli2001@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC
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