NCT02632201

Immunotherapy Using Pluripotent Killer-Human Epidermal Growth Factor Receptor-2 (PIK-HER2) Cells for the Treatment of Advanced Gastric Cancer With Liver Metastasis

A Clinical Study of Adoptive Cellular Immunotherapy Using Pluripotent Killer T Cells Expressing Antibodies for Human Epidermal Growth Factor Receptor-2 (HER2) in Treating Patients With HER2-Positive Advanced Gastric Cancer With Liver Metastasis

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Second Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Objectives: The purpose of this study is to evaluate the safety and efficacy of PIK-HER2 cells in the treatment of advanced Her2 high expressed gastric cancer with liver metastasis patients. Methods: This study designs a novel therapy using PIK-HER2 cells. 40 Her2 positive patients with liver metastasis from gastric cancer will be enrolled. They are randomly divided into dendritic cell-precision multiple antigen T cells (DC-PMAT) group and PIK-HER2 cells group. Both DC-PMAT treatment and PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.

Detailed description

A total of 40 patients may be enrolled over a period of 1-2 years.

Conditions

• Liver Metastasis
• Gastric Cancer

Interventions

Type	Name	Description
BIOLOGICAL	PIK-HER2	DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PIK-HER2 cell suspension (1-6×109 PIK-HER2 + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.
BIOLOGICAL	DC-PMAT	DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PMAT cell suspension (1-6×109 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-03-01
• Completion: 2017-09-01
• First posted: 2015-12-16
• Last updated: 2016-01-01

Locations

1 site across 1 country: China