Description:
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).
Title
- Brief Title: Anti-GPC3 CAR-T for Treating GPC3-positive Advanced Hepatocellular Carcinoma (HCC)
- Official Title: Phase I Trial of Anti-GPC3 Chimeric T Cells for Subjects With GPC3-Positive Advanced Hepatocellular Carcinoma
Clinical Trial IDs
- ORG STUDY ID:
GPC3CAR
- NCT ID:
NCT03084380
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs | | anti-GPC3 CAR-T |
Fludarabine | | anti-GPC3 CAR-T |
Cyclophosphamide | | anti-GPC3 CAR-T |
Purpose
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).
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
Trial Arms
Name | Type | Description | Interventions |
---|
anti-GPC3 CAR-T | Experimental | Transcatheter arterial chemoembolization (TACE) combine with GPC3-CART infusion | - Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs
- Fludarabine
- Cyclophosphamide
|
Eligibility 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
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety: Measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 |
Time Frame: | 4 weeks |
Safety Issue: | |
Description: | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 |
Secondary Outcome Measures
Measure: | Efficacy: Overall complete remission rate defined by the standard response criteria |
Time Frame: | 8 weeks |
Safety Issue: | |
Description: | Overall complete remission rate defined by the standard response criteria |
Measure: | Persistence: Duration of CAR-positive T cells in circulation |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Duration of CAR-positive T cells in circulation |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Xinqiao Hospital of Chongqing |
Last Updated
March 20, 2017