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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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ClinicalTrials.gov Identifier: NCT02632019
Recruitment Status : Unknown
Verified September 2015 by Second Military Medical University.
Recruitment status was:  Recruiting
First Posted : December 16, 2015
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
Second Military Medical University

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.


Condition or disease Intervention/treatment Phase
Advanced Biliary Tract Malignant Tumor Drug: Gemcitabine Biological: Dendritic cell-precision T cell for neo-antigen combined with gemcitabine treatment Phase 1 Phase 2

Detailed Description:
A total of 40 patients may be enrolled over a period of 1-2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: gemcitabine
Gemcitabine treatments will be performed once a week with a total of six times
Drug: Gemcitabine
Gemcitabine 1000mg/m2, Physiological saline 100ml:IV (in the vein) once a week with a total of six times.

Experimental: Dendritic cell-precision T cell for neo-antigen
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.
Drug: Gemcitabine
Gemcitabine 1000mg/m2, Physiological saline 100ml:IV (in the vein) once a week with a total of six times.

Biological: Dendritic cell-precision T cell for neo-antigen combined with gemcitabine treatment

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 Measures :
  1. Overall survival [ Time Frame: 2 yeas ]

Secondary Outcome Measures :
  1. Progress-free survival [ Time Frame: 2 yeas ]
  2. Quality of life [ Time Frame: 2 yeas ]
    Quality of life core questionnaire will be used.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632019


Contacts
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Contact: Qijun Qian, PHD +86-21-65580677 qianqj@sino-gene.cn
Contact: Huajun Jin, PHD +86-21-81875372 hj-jin@Hotmail.com

Locations
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China
Eastern Hepatobiliary Surgery Hospital Recruiting
Shanghai, China, 200438
Contact: Huajun Jin, PHD    +86-21-81875372    hj-jin@hotmail.com   
Principal Investigator: Xiaoqing Jiang, MD         
Principal Investigator: Qijun Qian, PHD         
Principal Investigator: Huajun Jin, PHD         
Principal Investigator: Xiangji Luo, PHD         
Sub-Investigator: Yao Huang, MD         
Sub-Investigator: Jinghan Wang, MD         
Sub-Investigator: Chang Hu, MD         
Sub-Investigator: Xiaoxia Kou, MD         
Sponsors and Collaborators
Second Military Medical University
Investigators
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Study Chair: Xiaoqing Jiang, MD Eastern Hepatobiliary Surgery Hospital

Publications:

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Responsible Party: Second Military Medical University
ClinicalTrials.gov Identifier: NCT02632019     History of Changes
Other Study ID Numbers: EHBHKY2015-02-006
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: September 2015

Keywords provided by Second Military Medical University:
advanced biliary tract malignant tumor
dendritic cell
precision T cell for neo-antigen

Additional relevant MeSH terms:
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Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs