NCT02876978

Anti-GPC3 CAR T for Recurrent or Refractory Lung Squamous Cell Carcinoma

Preliminary Clinical Study of Autologous T Cells Modified Chimeric Antigen Receptor (CAR) Targeting GPC3 for the Treatment of Recurrent or Refractory Lung Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: CARsgen Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe and confirm the safety, tolerance and cell pharmacokinetics of lentivirus-transduced CAR-GPC3 T cells (CAR-GPC3 T cells targeting GPC3)

Detailed description

A single-center, open-label pilot study to determine the safety, tolerance and engraftment potential of CAR-GPC3 T cells in subjects with GPC3+ positive lung squamous cell carcinoma. Primary objectives: Observe and determine the safety and tolerance in escalating dose infusion of CAR-GPC3 T cells (CAR T cells targeting GPC3) transduced with the lentiviral vector, and the survival of the CAT-GPC3 T cells in vivo, referred to as engraftment potential. Secondary objectives: The following indexes are monitored for curative effect of CAR-GPC3 T cells on lung squamous cell carcinoma: 1. Objective response rate (ORR), is defined as the ratio of patients diagnosed as partial remission (PR) to complete remission (CR) according to RECIST 1.1 criteria. 2. Progression free survival (PFS), is defined as the duration from baseline to PD (audited and confirmed by independent imaging), or to the day of any death event. The earlier one shall prevail. 3. Time to tumor progression (TTP), is defined as the duration from baseline to disease starts to get worse or spreads to other parts of the body. 4. Overall survival (OS), is defined as the time period from the 1st day of treatment to the day of death for any reason. For patients who are still alive at the data analysis day, OS data is subject to the last confirmed time of survival patients.

Conditions

• Lung Squamous Cell Carcinoma

Interventions

Type	Name	Description
GENETIC	CAR-GPC3 T Cells	Intravenous infusion of CAR-GPC3 T cells is conducted 1 - 2 days following lymphodepletion.
DRUG	Fludarabine	30 mg/m\^2/day x 4 days
DRUG	Cyclophosphamide	500 mg/m\^2/day x 2 days

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-10-01
• Completion: 2019-04-01
• First posted: 2016-08-24
• Last updated: 2016-08-24

Locations

1 site across 1 country: China