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A Study of GPC3-targeted T Cells by Intratumor Injection for Advanced HCC (GPC3-CART)

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: NCT03130712
Recruitment Status : Unknown
Verified April 2017 by Shanghai GeneChem Co., Ltd..
Recruitment status was:  Recruiting
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Beijing 302 Hospital
Information provided by (Responsible Party):
Shanghai GeneChem Co., Ltd.

Study Description
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Brief Summary:
In this study, CART cells are targeted to GPC3 by intratumor injected that we hope by this means could improve the local CAR-T cell numbers, meanwhile reduce the potential side effects.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: GPC3-CART cells Phase 1 Phase 2

Detailed Description:
Patients treated with leukapheresis to obtain peripheral blood mononuclear cells, and then PBMC are purified. T cells are activated and then re-engineered to express chimeric antigen receptors (CARs) specific for GPC3. Cells are expanded in culture and returned to the participant by intratumor injection at the dose of(1-10)×106 CAR positive T cells. The cells perfusion process would only last for (1-2) min. GPC-CART cells are injected into each tumor focus only once.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Uncontrolled, Single-arm Pilot Study to Evaluate Intratumor Injection Mediated GPC3-targeted Chimeric Antigen Receptor T Cells in Advanced Hepatocellular Carcinoma
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: GPC3-CART cells Drug: GPC3-CART cells
Intratumol injection as a local drug delivery pathway, so that more T cells gathered at the tumor site, less T cells to migrated to the normal tissue, thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects. And GPC3-CART is a 2nd CAR, with GPC3 as the target protein, 4-1BB as a co- stimulator


Outcome Measures
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Primary Outcome Measures :
  1. Safety of CAR-T cell infusion mediated by intratumoral injection as measured by number of participants with adverse Events [ Time Frame: 6 weeks ]
    To determine the safety and regimen limiting toxicity (RLT) of anti-GPC3 CAR-T intratumoral injection for GPC3-expressing HCC.


Secondary Outcome Measures :
  1. Number of participants with tumor response as measured by RECIST [ Time Frame: 8 weeks] ]
  2. Serum cytokine levels [ Time Frame: 8 weeks ]
    Measurement of cytokines as indicators of immune response, including IL-2/IL-6/IL-10/TNF/IL-2R


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Advanced HCC patients with age between 18 and 69 years old;
  • Persistent cancer after at least one prior standard of chemotherapy or surgery, and without high level evidence of second-line treatment;
  • The intended intratumoral injection sites of tumor can be showed clear by CT or ultrasound scan, and safe access to without important neuromuscular pass;
  • The ECOG score less than 1 points, and the expected survival more than 4 months;
  • Recovery from previous treatment: all side effects (except hair loss) were reduced to level 1 or below, according to NCI-CTC AE version 4;
  • Pregnancy test (urine beta -HCG) negative (for women of childbearing age);

  • Meet one of the following conditions:

    1. GPC3 was expressed in more than 15% of tumor cells (immunohistochemical method)
    2. GPC3 expression in more than 30% of tumor cells (flow cytometry);
  • Satisfactory organ and bone marrow function as defined by the following: (1) creatinine <1.5mg/dl; (2) albumin >2; (3) cardiac ejection fraction of >55%; (4) hemoglobin>9g/dl, bilirubin 2.0×the institution normal upper limit;
  • Adequate venous access for apheresis;
  • Voluntary informed consent.

Exclusion Criteria:

  • Pregnant or lactating women, urine pregnancy test was positive before transplantation of CAR-T cells 48 hours;
  • 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;
  • Forced position, can not be adjusted according to requirements;
  • Severe heart, lung, liver, kidney function, blood coagulation dysfunction;
  • 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): NCT03130712


Contacts
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Contact: Lu Yinying, Doctor 13301256799 luyinying1973@163.com
Contact: Yu Xuejun, Master 18616108610 yuxuejun@genechem.com.cn

Locations
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China
302 Military Hospital Recruiting
Beijing, China
Contact: Lu Yinying, Doctor    13301256799    luyinying1973@163.com   
Sponsors and Collaborators
Shanghai GeneChem Co., Ltd.
Beijing 302 Hospital
Investigators
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Principal Investigator: Lu Yinying, Doctor Beijing 302 Hospital
More Information
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Responsible Party: Shanghai GeneChem Co., Ltd.
ClinicalTrials.gov Identifier: NCT03130712    
Other Study ID Numbers: 302 GPC3-CART
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai GeneChem Co., Ltd.:
immunotherapy
GPC3-CART
HCC
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases