Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anti-GPC3 CAR-T for Treating GPC3-positive Advanced Hepatocellular Carcinoma (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: NCT03084380
Recruitment Status : Unknown
Verified March 2017 by Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing.
Recruitment status was:  Not yet recruiting
First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing

Brief Summary:
The goal of this clinical trial is to evaluate the safety and efficacy of anti-GPC3 scFv-41BB-CD3ζ-tEGFR chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with GPC3-positive advanced hepatocellular carcinoma (HCC).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Biological: Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs Drug: Fludarabine Drug: Cyclophosphamide Phase 1 Phase 2

Detailed Description:

Primary Objectives:

  1. To evaluate the safety of intravenous administration of the anti-GPC3 CAR-T cells in patients with HCC or lung squamous cell carcinoma
  2. To access the safety of anti-GPC3 CAR-T cells in HCC patients through catheter injection

Secondary Objectives:

  1. To evaluate the efficacy of anti-GPC3 CAR-T cells in patients with advanced HCC or lung squamous cell carcinoma
  2. To monitor the serum cytokine and expression level of tumor markers such as AFP, CEA and GPC3
  3. To assess the persistence in peripheral blood and intratumoral infiltration of anti-GPC3 CAR-T cells

Layout table for study information
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: Phase I Trial of Anti-GPC3 Chimeric T Cells for Subjects With GPC3-Positive Advanced Hepatocellular Carcinoma
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2020

Arm Intervention/treatment
Experimental: anti-GPC3 CAR-T
Transcatheter arterial chemoembolization (TACE) combine with GPC3-CART infusion
Biological: Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs
transcatheter arterial chemoembolization + CAR-T infusion

Drug: Fludarabine
Fludarabine will be administered at dose of 25mg/m2/d

Drug: Cyclophosphamide
Cyclophosphamide will be administered at dose of 40mg/kg for 1 day and then fludarabine will be given for the next 5 days and then the T cells will be administered




Primary Outcome Measures :
  1. Safety: Measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 [ Time Frame: 4 weeks ]
    Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0


Secondary Outcome Measures :
  1. Efficacy: Overall complete remission rate defined by the standard response criteria [ Time Frame: 8 weeks ]
    Overall complete remission rate defined by the standard response criteria

  2. Persistence: Duration of CAR-positive T cells in circulation [ Time Frame: 6 months ]
    Duration of CAR-positive T cells in circulation



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Expected to survive more than 3 months
  • PS 0-2
  • Immunohistochemistry was confirmed to be GPC3 positive hepatocellular carcinoma
  • Patients with no ability to receive TACE combined with sorafenib
  • WBC>3.5×1e+9/L,Hb>90g/L,PLT>75×1e+9/L
  • HBV DNA copy number less than 100/ml
  • ALT≤5ULN, AST≤5ULN, TB≤1.5ULN, ALB≥35g/L
  • Understand this test and have signed informed consent

Exclusion Criteria:

  • Hepatic encephalopathy, autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial
  • Decompensated liver cirrhosis, liver function Child-pugh C grade
  • Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous
  • Long-term use of immunosuppressive agents after organ transplantation
  • Screening indicated that the target cell transfection rate was less than 30%
  • Invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization
  • Subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization
  • Pregnant or lactating subjects
  • In the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration
  • Subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study

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): NCT03084380


Locations
Layout table for location information
China, Chongqing
Department of Oncology, Xinqiao Hospital
ChongQing, Chongqing, China, 400037
Sponsors and Collaborators
Xinqiao Hospital of Chongqing
Layout table for additonal information
Responsible Party: Qingzhu Jia, M.D., Secretary of research, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT03084380    
Other Study ID Numbers: GPC3CAR
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists