NCT04076137

Targeted T-cell Therapy in Solid Tumors

Clinical Study of Targeted T-cell Therapy in Solid Tumors

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Benhealth Biopharmaceutical (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open, single-arm controlled prospective clinical trial of patients with solid tumors treated with targeted activation of T cells through intravenous infusion.The purpose of this study was to evaluate the clinical efficacy and safety of targeted activated T cells in the treatment of solid tumors.

Detailed description

In China, malignant tumors have become the leading cause of death for urban and rural residents, with solid tumors accounting for 77 percent.Immunotherapy is considered one of the most promising ways to fight cancer.This study is a single-center, open, single-arm controlled clinical trial (after intravenous infusion of targeted T cells, compare the changes of self-lesion). The essence of this study is to collect immune cells to the surrounding of tumor cells, so that immune cells can kill tumor cells at close range.The researchers plan to enroll 10 patients with solid tumors and follow them up to the end of the study after completing 9 courses of treatment.The results of this study were statistically analyzed using RECIST1.1 records.

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
OTHER	Targeted T-cell armed with bispecific antibody (Decitabine)	In this study, 10 patients eligible for the study were clinically screened for intravenous infusion of targeted activated T cells,every participant has a unique identification number and emergency letter which have the information of group.

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-05-01
• Completion: 2021-05-01
• First posted: 2019-09-03
• Last updated: 2019-09-03

Locations

1 site across 1 country: China