CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 30 target
Drug / intervention
GPC3 and/or TGFβ targeting CAR-T cellsbiological
Likely dose
Not stated in record
Key inclusion· 7
  • Advanced HCC with GPC3 protein expression
  • Life expectancy greater than 12 weeks
  • Child-Pugh-Turcotte score less than 7
  • Adequate heart, lung, liver, kidney function
Key exclusion· 8
  • Prior gene therapy
  • Tumor size greater than 25 cm
  • Severe viral infection (HBV, HCV, HIV)
  • Known HIV positivity

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03198546
NCT03198546Phase 1RecruitingOn TrackUpdated 24mo ago
Long Recruiting

CAR-T Cell Targeting GPC3 for Immunotherapy of Hepatocellular Carcinoma: Phase I Clinical Trial

Second Affiliated Hospital of Guangzhou Medical University·interventional·Posted Jun 26, 2017·Updated Jun 25, 2024

In Brief

A Phase 1 clinical trial evaluating GPC3 and/or TGFβ targeting CAR-T cells for Hepatocellular Carcinoma and 5 related conditions. Currently recruiting, targeting 30 participants across 2 sites.

Detailed Summary

The third/fourth generation of CAR-T cells that target GPC3 (GPC3-CART cell) and/or soluble TGFβ (GPC3/TGFβ-CART )have been constructed and their anti-HCC function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test the anti-cancer function by the GPC3/TGFβ-CAR-T cells in human HCC patients with GPC3 expression. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/TGFβ-CAR-T cell immunotherapy on human will firstly be tested.

Study Details

Timeline

Phase 1Recruiting
201720182019202020212022202320242025202620272028202920302031203220332034203520362037
First PostedJun 26, 2017
Enrollment StartJul 1, 2017
Primary CompletionAug 1, 2029
Study CompletionAug 1, 2036
TodayJul 1, 2026
Enrollment to primary: 12.1 yearsPosted 9.0 years agoPrimary completion in 3.1 years

Interventions

GPC3 and/or TGFβ targeting CAR-T cellsbiological

Engineering GPC3 or/and TGFβ targeting CAR combined with/or without IL7/CCL19 and/or scfv against PD1/CTLA4/Tigit secreting vector into T cells with knockdown of PD1/HPK1, which are isolated from patients with advanced HCC, and then transfusing them back the patients.