NCT02725125

Study Evaluating the Efficacy and Safety With CAR-T for Stomach Cancer

Single-arm,Two Phase,Multicenter Trial to Evaluating the Efficacy and Safety of the CAR-T for Stomach Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Sinobioway Cell Therapy Co., Ltd. · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

This single-arm, multicenter Phase 2 trial will treat the patients who have relapsed or refractory stomach cancer with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR) that will bind to tumor cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumor cells.The trial will also study the safety of treatment with CAR-T, how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.

Detailed description

This is a single-arm, multicenter Phase 2 study to evaluate the efficacy and safety of the CAR-T for Stomach Cancer. The study will be conducted using a phaseⅠ /Ⅱ design.The study will have the following sequential phases: Part A(screening leukapheresis, cell product preparation, and cytoreductive chemotherapy) and Part B(treatment and follow-up). The follow-up period for each participant is approximately 35 months after the final CAR-T infusion.The total duration of the study is expected to be approximately 3 years. A total of 19 patients may be enrolled over a period of 3 years.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	EPCAM-targeted CAR-T cells	This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-EPCAM-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2016-03-31
• Last updated: 2017-03-23

Locations

1 site across 1 country: China