- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02723942
CAR-T Cell Immunotherapy for HCC Targeting GPC3
July 14, 2020 updated by: Fuda Cancer Hospital, Guangzhou
Chimeric Antigen Receptor-Modified T Cell (CAR-T) Immunotherapy for Hepatocellular Carcinoma (HCC) Targeting Glypican-3 (GPC3)
The purpose of this study is to preliminarily evaluate the safety and efficacy of CAR-T cell immunotherapy for GPC3 positive hepatocellular carcinoma.
Study Overview
Status
Withdrawn
Intervention / Treatment
Detailed Description
Chimeric antigen receptor (CAR) is a recombinant receptor with both antigen-binding and T cell activating functions.
Chimeric antigen receptor T cell Immunotherapy has more advantages compared with conventional immunotherapy, especially in dealing with patients of hematologic malignancies and solid malignant tumors.This study design a novel specific Chimeric antigen receptor targeting glypican-3(GPC3) antigen.After CAR-T cell infusion,At periodic intervals, the investigators will evaluate clinical symptoms Improved conditions of this disease.Through this study,the investigators will evaluate the safety and efficacy of CAR-T cell immunotherapy in treating with GPC3 positive malignant glioma patients.
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Central laboratory in Fuda cancer hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age:18-70 years.
- Gender:both.
- GPC3 high expression hepatocellular carcinoma patients.
- Non diffuse hepatocellular carcinoma,no extrahepatic metastasis or portal vein vascular invasion.
- Degree of liver cirrhosis:class A or class B 7 according to Child-puge grading standard.
- Routine blood test:white blood cell count(WBC)>=3×10^9/L, Lymphocyte percentage>=15%, hemoglobinHbo(Hb)>=90g/L, prothrombin time(PT) prolongation<=50% normal value, Cluster of differentiation 3(CD3) positive T cell count>=0.8×10^9/L.
- Liver and Pancreatic function:Alanine aminotransferase/Aspartate transaminase(ALT/AST)<=5 times of the normal value, total bilirubin(TBiL)<=3.0mg/dL, albumin(ALB)>=35g/L, prothrombin time(PT):International Normalized Ratio(INR)<=1.7 or prothrombin time(PT) prolongation<=4s, Serum lipase<=1.5 times of the normal value, Serum amylase<=1.5 times of the normal value.
- Renal function:Serum creatinine(SCr)<=221μmol/L(2.5mg/L).
- Karnofsky Performance Status(KPS)>=60;Expected survival time>=12 weeks.
- Peripheral venous access ;no contraindication of lymphocyte separation.
- No other serious complications.
- Voluntarily signed informed consent.
Exclusion Criteria:
- Pregnant and lactating women.
- Lymphocyte separation or peripheral venous access cannot be performed in patients .
- Patients in the active stage of infection or with coagulation disorders.
- Patients with a previous history of hepatic coma.
- Patients with severe gastrointestinal ulcers or gastrointestinal bleeding.
- Patients with organ transplantation or waiting for organ transplantation.
- Patients with anticoagulant therapy.
- Patients with antiplatelet therapy.
- Serum sodium(Na)<125 mmol/L.
- Serum potassium(K)<3.5 mmol/L(except patients up to the standards after the use of supplements).
Patients with organ failure:
- cardiac function:level three or above according to New York Heart Association (NYHA) criteria.
- liver function:class C or above according to Child-puge grading standard.
- renal function:Chronic kidney disease(CKD) phase 4 or more; renal insufficiency phase Ⅲ or more.
- pulmonary function:severe respiratory failure symptoms, involving other organs.
- Brain function:central nervous system abnormalities or disturbance of consciousness.
- Patients with non controlled infectious diseases,for example,HIV positive, syphilis, hepatitis A, hepatitis B, hepatitis C, hepatitis E virus (HEV) positive etc.
- Patients used corticosteroids or other immunosuppressive agents in the past 4 weeks.
- Patients with autoimmune disease.
- Patients with previous history of gene therapy.
- The actual transfection rate of T cells was lower than 30% or the proliferation was less than 5 times after costimulation.
- Patients participated in other drug trials in the past 4 weeks.
- Patients received radiation treatment in the past 4 weeks.
- Patients do not meet the criteria above.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GPC3 antigen by infusion.
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This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GPC3 antigen.
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NO_INTERVENTION: no intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiological assessment
Time Frame: 3 months
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Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The safety of CAR-T cell immunotherapy (adverse events)
Time Frame: 4 weeks
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After CAR-T cell infusion,we will observe the potential adverse events related to the T-cell infusion such as high fever,jaundice, kidney failure and so on.
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4 weeks
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Peripheral blood tumor markers
Time Frame: 3 months
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tested regularly to reflect the role of the Chimeric Antigen Receptor-Modified T Cell in the removal of residual tumor cells.
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3 months
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CAR-T cell testing
Time Frame: 3 months
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The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry to evaluate the proliferation in vivo and long-term survival.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2015
Primary Completion (ACTUAL)
August 15, 2016
Study Completion (ACTUAL)
August 15, 2016
Study Registration Dates
First Submitted
March 20, 2016
First Submitted That Met QC Criteria
March 24, 2016
First Posted (ESTIMATE)
March 31, 2016
Study Record Updates
Last Update Posted (ACTUAL)
July 16, 2020
Last Update Submitted That Met QC Criteria
July 14, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAR-T for GPC3+ HCC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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