NCT03084380

Anti-GPC3 CAR-T for Treating GPC3-positive Advanced Hepatocellular Carcinoma (HCC)

Phase I Trial of Anti-GPC3 Chimeric T Cells for Subjects With GPC3-Positive Advanced Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

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

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-05-31
• Completion: 2020-05-31
• First posted: 2017-03-20
• Last updated: 2017-03-20

Locations

1 site across 1 country: China