NCT02662348

T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Yi Miao · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is to investigate the safety and the possible side effects of bi-specific antibody armed T-cell therapy when given together with low-dose IL-2 in treating patients with Her2-positive neoplasms of digestive system. Expanded autologues T cells that have been coated with bi-specific antibodies, such as anti-CD3 and anti-human epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells from growing. Interleukin-2 may stimulate white blood cells to kill tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. Perform a phase I clinical trial to clearly define the toxicity profile of IV HER2Bi armed T cells in patients with neoplasms of digestive system. SECONDARY OBJECTIVES: I. Evaluate phenotype, cytokine profiles and tumor markers, cytotoxicity directed at laboratory Her2 positive cancer cell lines. II. Evaluate the clinical symptoms and signs, clinical responses, imaging examination of pretherapy and post-treatment, cytokine profiles and tumor markers in serum before and after treatment, time to progression, and overall survival. OUTLINE: This is a safety study of IV infused HER2Bi-armed activated T cells. Patients receive HER2Bi armed T cells IV weekly for 4 weeks. Patients also receive low-dose Interleukin subcutaneously (SC) daily beginning 3 days before the first HER2Bi armed T cells infusion. Treatment continues in the absence of disease progression or unacceptable toxicity.

Conditions

• Esophageal Cancer
• Gastric Cancer
• Pancreatic Cancer
• Liver Cancer
• Gallbladder Cancer
• Bowel Cancer

Interventions

Type	Name	Description
DRUG	Recombinant Human Interleukin-2	Given SC
DRUG	HER2Bi-Armed T Cells	Given IV

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2016-01-25
• Last updated: 2016-01-25

Locations

1 site across 1 country: China