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

Sponsor
Shanghai GeneChem Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02959151
Collaborator
Shanghai Cancer Hospital, China (Other)
20
Enrollment
1
Location
1
Arm
24
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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 :
Jul 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Jul 1, 2018

Arms and Interventions

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 Names:
  • chimeric antigen receptor T cells

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with adverse event [6 weeks]

      adverse event is evaluated with CTCAE, version 4.0

    Secondary Outcome Measures

    1. Number of patients with tumor response [8 weeks]

      summarize tumor response by overall response rates

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Shanghai Tumor Hospital Shanghai Shanghai China 201206

    Sponsors and Collaborators

    • Shanghai GeneChem Co., Ltd.
    • Shanghai Cancer Hospital, China

    Investigators

    • Principal Investigator: Wentao Li, doctor, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai GeneChem Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02959151
    Other Study ID Numbers:
    • CAR-T for liver cancer
    First Posted:
    Nov 8, 2016
    Last Update Posted:
    Nov 8, 2016
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Neoplasms
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Nov 8, 2016