Anti-GPC3 CAR-T for Treating GPC3-positive Advanced Hepatocellular Carcinoma (HCC)
NCT ID: NCT03084380
Last Updated: 2017-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2017-06-01
2020-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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anti-GPC3 CAR-T
Transcatheter arterial chemoembolization (TACE) combine with GPC3-CART infusion
Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs
transcatheter arterial chemoembolization + CAR-T infusion
Fludarabine
Fludarabine will be administered at dose of 25mg/m2/d
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
Interventions
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Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs
transcatheter arterial chemoembolization + CAR-T infusion
Fludarabine
Fludarabine will be administered at dose of 25mg/m2/d
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Xinqiao Hospital of Chongqing
OTHER
Responsible Party
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Qingzhu Jia, M.D.
Secretary of research
Locations
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Department of Oncology, Xinqiao Hospital
Chongqing, Chongqing Municipality, China
Countries
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Other Identifiers
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GPC3CAR
Identifier Type: -
Identifier Source: org_study_id
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