NCT03551795

Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Xiaoyan Zhang · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells.The hypothesis of the investigators is that immunotherapy strategy of infusion of iNKT cells may resist inflection and decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of tuberculosis with malignant solid tumor by infusing of iNKT cells.

Detailed description

Treatment of tuberculosis with malignant solid tumor is great unsolved challenge to the physicians. Efficacy of conventional treatment, such as surgery, radiotherapy and chemotherapy is limited. AS novel therapy, immunotherapy shows great prospects. Human iNKT cells can directly lysis tumor cells by a perforin-dependent mechanism,and intracellular granzyme B expression may also potentiate cell killing. Tumor cells expressing CD1d may be especially susceptible to direct NKT cell lysis. iNKT cells play important role in immune regulation by secreting various cytokines. Expansion method of iNKT cells in vitro is developed as published in the patent of the investigators. Infusion of iNKT cells has been proved safe in mice. In this clinical trial, the safety and efficacy of the immunotherapy of infusion of iNKT cells are assessed.

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Infusion of iNKT cells	The eligible patients receive twice infusions of iNKT cells(1E8\~1E10) in one course of treatment.

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-12-30
• Completion: 2022-03-31
• First posted: 2018-06-11
• Last updated: 2022-05-09

Locations

1 site across 1 country: China