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GPC3-targeted CAR-T Cell for Treating GPC3 Positive Advanced HCC

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: NCT04121273
Recruitment Status : Unknown
Verified March 2021 by Beicheng Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was:  Recruiting
First Posted : October 9, 2019
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Beicheng Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description
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Brief Summary:

Patients with hepatocellular carcinoma (a type of primary liver cancers) are enrolls in this study. The cancer has progressed after standard treatment, or the patient cannot receive regular treatment.

Investigator made a gene called chimeric antigen receptor derived from an antibody that recognizes Glypican 3, a protein detected in in a large proportion of hepatocellular carcinoma. The gene will introduce into T cell from patient's blood to make them recognize and kill cancer cells.

The aim of this study is to evaluate the efficacy, tolerance and safety of chimeric antigen receptor-modified T (CAR-T) cell targeting Glypican 3 for advanced hepatocellular carcinoma.


Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Biological: CAR-T cell immunotherapy Phase 1

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: Clinical Study of GPC3-targeted Chimeric Antigen Receptor T Cells fo Treating Advanced Hepatocellular Carcinoma
Actual Study Start Date : October 5, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : November 1, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: CAR-T cells
CAR-T cells targeting GPC3 will be administered to enrolled patients with hepatocellular carcinoma.
 Biological: CAR-T cell immunotherapy

Patients enrolled will recieve three different doses of the CAR-T cell every two weeks as follows:

Dose 1: 1x10^7/m2

Dose 2: 3x10^7/m2

Dose 3: 1x10^8/m2

The cell numbers are calculated according to CAR-positive T cells.


Outcome Measures
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Primary Outcome Measures :
  1. Number of patient with dose limiting toxicity [ Time Frame: 2 months ]
    After each dose of T cell infusion, the adverse effects related to T cell therapy such as fever and jaundice are observed.


Secondary Outcome Measures :
  1. Radiological evaluation of tumor size after CAR- T immunotherapy [ Time Frame: 3 months ]
    Evaluate the therapeutic effect of CAR-T immunotherapy radiological observation of the tumor size after infusion of CAR-T cells.

  2. Peripheral tumor marker [ Time Frame: 3 months ]
    After CAR-T cell infusion, alpha fetoprotein (AFP) will be tested regularly in blood.

  3. Number of Peripheral CAR-T cell [ Time Frame: 3 months ]
    The number and proliferation in vivo are tested with Flow Cytometry regularly.


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  1. GPC3 positive HCC, tumor size >= 5 cm, cannot receive standard treatment, Expected survival time>=3 months.
  2. Routine blood test: white blood cell count（WBC)>= 2.5×10^9/L, hemoglobin (Hb)>= 9.0 g/dL, blood platelet >= 60×10^9/L, Lymphocyte percentage>=15%.
  3. Blood biochemical parameters: ALB >= 30 g/L, ALT <= 5 times of the normal value, AST <= 5 times of the normal value, serum lipase<=1.5 times of the normal value, serum amylase<=1.5 times of the normal value， total bilirubin <= 2.5 times of the normal value.
  4. Prothrombin time INR < 1.7.
  5. Ejection fraction (EF) >= 55%, oxygen saturation (SO2) > 90%.
  6. No allergic reaction to contrast material.
  7. Karnofsky score >= 60%.
  8. Child-puge score <7.
  9. Peripheral venous access.
  10. Voluntarily signed informed consent.

Exclusion Criteria:

  1. Pregnancy or lactation.
  2. Systemic steroid treatment ( >prednisone equivalent/kg/day).
  3. Patients with previous history of cell immunotherapy or antibody therapy.
  4. Patients received radiotherapy/chemotherapy in the past 4 weeks.
  5. Patients are participating in other clinical trials.
  6. Patients with uncontrolled symptoms including infection, heart failure, arrhythmia.
  7. Patients with acute allergic reaction.
  8. History of liver transplantation.
  9. Patients with anticoagulant treatment.
  10. Patients with hepatic encephalopathy.
  11. Eligible for hepatectomy, liver transplantation or other standard treatment.
  12. Unstable gastrointestinal and respiratory bleeding.
  13. Active viral, fungal or bacterial infections.
  14. Heart failure classification (NYHA): II-IV.
  15. Patients are unable or unwilling to comply with the requirements of the study protocol.
  16. Patients do not meet the criteria above.
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): NCT04121273


Contacts
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Contact: Decai Yu, MD 8613701585023 yudecai@nju.edu.cn
Contact: Wenfang Tian, PhD 8613675104348 tiancpu@163.com

Locations
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China, Jiangsu
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Wenfang Tian, PhD    8613675104348    tiancpu@163.com   
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
More Information
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Responsible Party: Beicheng Sun, Director of Hepatobiliary Surgery, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT04121273    
Other Study ID Numbers: v1.0 20180620
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Beicheng Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
chimeric antigen receptor T cell (CAR- T)
glypican-3 (GPC3)
hepatocellular carcinoma (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
Immunomodulating Agents
Immunologic Factors
Physiological Effects of Drugs