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A Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02959151
Recruitment Status : Unknown
Verified November 2016 by Shanghai GeneChem Co., Ltd..
Recruitment status was:  Recruiting
First Posted : November 8, 2016
Last Update Posted : November 8, 2016
Sponsor:
Collaborator:
Shanghai Cancer Hospital, China
Information provided by (Responsible Party):
Shanghai GeneChem Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to collect the date on the safety and potential effectiveness of CART cells combined with interventional therapy in patients with advanced liver malignancy.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Pancreatic Cancer Metastatic Colorectal Cancer Metastatic Drug: CAR-T cell Phase 1 Phase 2

Detailed Description:
Designer T cells are prepared by PBMC which from patients or suitable donator by leukapheresis, and then activated and re-engineered to express chimeric antigen receptors (CARs). There are three options for CAR-targets: GPC3 for hepatocellular carcinoma; mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic. Cells are expanded in culture and returned to the participant by vascular interventional therapy or by intra-tumor injection at the dose of （1.25~4）×107 CAR positive T cells/cm3 tumor bulk. The volume of cell products and the time of cell perfusion process lasted would depend on the ways of cell perfused.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm Pilot Clinical Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy
Study Start Date : July 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CAR-T for liver cancer
A single dose of CART cells will be administered by vascular interventional therapy or by intra-tumor injection with a dose of （1.25~4）×107 CAR positive T cells/cm3 tumor bulk. The volume of cell products and the time of cell perfusion process lasted would depend on the ways of cell perfused. And an interventional radiologist would operate the cell infusion.
 Drug: CAR-T cell
CAR-T cells are generated by T cells from the patients or a suitable donor transfected by CAR-lentivirus vectors. There are three options for CAR-targets: GPC3 for hepatocellular carcinoma;mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic.
Other Name: chimeric antigen receptor T cells


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with adverse event [ Time Frame: 6 weeks ]
    adverse event is evaluated with CTCAE, version 4.0


Secondary Outcome Measures :
  1. Number of patients with tumor response [ Time Frame: 8 weeks ]
    summarize tumor response by overall response rates

  2. Detection of transferred T cells in the circulation using quantitative -PCR [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • tumor histological examination confirmed as GPC3/ mesothelin/CEA positive expression;
  • persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients
  • life expectancy greater than 6 months
  • satisfactory organ and bone marrow function as defined by the following: (1) creatinine <1.5mg/dl; (2) cardiac ejection fraction of >55%; (3) hemoglobin>9g/dl, bilirubin 2.0×the institution normal upper limit
  • without bleeding disorder or coagulation disorders
  • Don't allergy to Radiocontrast agent
  • birth control
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis
  • Voluntary informed consent is given

Exclusion Criteria:

  • Pregnant or lactating women
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
  • patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before
  • Four weeks before recruit accepted radiation therapy
  • Previously treatment with any gene therapy products
  • Feasibility assessment during screening demonstrates<30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation
  • Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases)
  • Patient with severe acute hypersensitive reaction
  • Taking part in other clinical trials
  • Study leader considers not suitable for this tiral
Contacts and Locations
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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): NCT02959151


Contacts
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Contact: Wentao Li, doctor +86 18017312650 liwentao98@126.com
Contact: Xuejun Yu, master +86 18616108610 yuxuejun@genechem.com.cn

Locations
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China, Shanghai
Shanghai Tumor Hospital Recruiting
Shanghai, Shanghai, China, 201206
Contact: Wentao Li, doctor    + 86 18017312650    liwentao98@126.com   
Contact: Xuejun Yu, master    +86 18616108610    yuxuejun@genechem.com.cn   
Sponsors and Collaborators
Shanghai GeneChem Co., Ltd.
Shanghai Cancer Hospital, China
Investigators
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Principal Investigator: Wentao Li, doctor Fudan University
More Information
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Responsible Party: Shanghai GeneChem Co., Ltd.
ClinicalTrials.gov Identifier: NCT02959151    
Other Study ID Numbers: CAR-T for liver cancer
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Adenocarcinoma
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Liver Diseases