Back to resultsImmunotherapy Using Precision T Cells Specific to Personalized Neo-antigen for the Treatment of Advanced Malignant Tumor of Biliary Tract
Primary Purpose
Advanced Biliary Tract Malignant Tumor
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Gemcitabine
Dendritic cell-precision T cell for neo-antigen combined with gemcitabine treatment
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Biliary Tract Malignant Tumor focused on measuring advanced biliary tract malignant tumor, dendritic cell, precision T cell for neo-antigen
Eligibility Criteria
Inclusion Criteria:
- 1. Age 18~65 years old, male or female;2. Life expectancy > 6 months;3. Eastern Cooperative Oncology Group (ECOG) score: 0-2;4. Laboratory examination: ① white blood cell ≥ 3 x 109/L. blood platelet count ≥ 60 x 109/L; hemoglobin ≥85g/L; ② total bilirubin ≤100 mol/L; aminopherase less than five times of the normal; ③ serum creatinine less than 1.5 times of the normal;5. Signed informed consent;6. Patients with fertility are willing to use contraceptive method.
Exclusion Criteria:
- 1. Expected Overall survival < 6 months;2.Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, Etc.3.serum creatinine > 2.5mg/dL; Serum Glutamic Oxaloacetic Transaminase (SGOT) > 5 times of the normal;total bilirubin > 100μmol/L; 4.Other drugs, biological, chemotherapy or radiation therapy were used within 1 months;5. Without signed Informed consent.
Sites / Locations
- Eastern Hepatobiliary Surgery HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
gemcitabine
Dendritic cell-precision T cell for neo-antigen
Arm Description
Gemcitabine treatments will be performed once a week with a total of six times
Dendritic cell-precision T cell for neo-antigen (DC-PNAT) combined with gemcitabine treatment: Gemcitabine: once a week with a total of six times before 60 days prior to the start of drawing blood. DC-PNAT: once per 3 weeks with a total of three periods.
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Progress-free survival
Quality of life
Quality of life core questionnaire will be used.
Full Information
NCT ID
NCT02632019
First Posted
December 12, 2015
Last Updated
December 30, 2015
Sponsor
Second Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02632019
Brief Title
Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen for the Treatment of Advanced Malignant Tumor of Biliary Tract
Official Title
A Clinical Study of Adoptive Cellular Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen in Treating Patients With Advanced Malignant Tumor of Biliary Tract
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Military Medical University
4. Oversight
5. Study Description
Brief Summary
Objectives:
The purpose of this study is to evaluate the safety and prognosis of dendritic cell-precision T cell for neo-antigen in the treatment of advanced biliary tract malignant tumor.
Methods:
This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 40 patients will be enrolled. They are randomly divided into gemcitabine group and dendritic cell-precision T cell for neo-antigen combined with gemcitabine group. Gemcitabine treatments will be performed once a week with a total of six times. Dendritic cell-precision T cell for neo-antigen combined with gemcitabine treatment: Gemcitabine: once a week with a total of six times before 60 days prior to the start of drawing blood. Dendritic cell-precision T cell for neo-antigen: once per 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.
Detailed Description
A total of 40 patients may be enrolled over a period of 1-2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Biliary Tract Malignant Tumor
Keywords
advanced biliary tract malignant tumor, dendritic cell, precision T cell for neo-antigen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gemcitabine
Arm Type
Active Comparator
Arm Description
Gemcitabine treatments will be performed once a week with a total of six times
Arm Title
Dendritic cell-precision T cell for neo-antigen
Arm Type
Experimental
Arm Description
Dendritic cell-precision T cell for neo-antigen (DC-PNAT) combined with gemcitabine treatment: Gemcitabine: once a week with a total of six times before 60 days prior to the start of drawing blood. DC-PNAT: once per 3 weeks with a total of three periods.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1000mg/m2, Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
Intervention Type
Biological
Intervention Name(s)
Dendritic cell-precision T cell for neo-antigen combined with gemcitabine treatment
Intervention Description
Gemcitabine: Gemcitabine 1000mg/m2, Physiological saline 100ml: IV (in the vein) once a week with a total of six times before 60 days prior to the start of drawing blood. DC-PNAT: DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62.
PNAT cell suspension (1-6×109 PNAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
2 yeas
Secondary Outcome Measure Information:
Title
Progress-free survival
Time Frame
2 yeas
Title
Quality of life
Description
Quality of life core questionnaire will be used.
Time Frame
2 yeas
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Age 18~65 years old, male or female;2. Life expectancy > 6 months;3. Eastern Cooperative Oncology Group (ECOG) score: 0-2;4. Laboratory examination: ① white blood cell ≥ 3 x 109/L. blood platelet count ≥ 60 x 109/L; hemoglobin ≥85g/L; ② total bilirubin ≤100 mol/L; aminopherase less than five times of the normal; ③ serum creatinine less than 1.5 times of the normal;5. Signed informed consent;6. Patients with fertility are willing to use contraceptive method.
Exclusion Criteria:
1. Expected Overall survival < 6 months;2.Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, Etc.3.serum creatinine > 2.5mg/dL; Serum Glutamic Oxaloacetic Transaminase (SGOT) > 5 times of the normal;total bilirubin > 100μmol/L; 4.Other drugs, biological, chemotherapy or radiation therapy were used within 1 months;5. Without signed Informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qijun Qian, PHD
Phone
+86-21-65580677
Email
qianqj@sino-gene.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huajun Jin, PHD
Phone
+86-21-81875372
Email
hj-jin@Hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoqing Jiang, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huajun Jin, PHD
Phone
+86-21-81875372
Email
hj-jin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xiaoqing Jiang, MD
First Name & Middle Initial & Last Name & Degree
Qijun Qian, PHD
First Name & Middle Initial & Last Name & Degree
Huajun Jin, PHD
First Name & Middle Initial & Last Name & Degree
Xiangji Luo, PHD
First Name & Middle Initial & Last Name & Degree
Yao Huang, MD
First Name & Middle Initial & Last Name & Degree
Jinghan Wang, MD
First Name & Middle Initial & Last Name & Degree
Chang Hu, MD
First Name & Middle Initial & Last Name & Degree
Xiaoxia Kou, MD
12. IPD Sharing Statement
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Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen for the Treatment of Advanced Malignant Tumor of Biliary Tract
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