drugset / Trial / NCT02632019

Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen for the Treatment of Advanced Malignant Tumor of Biliary Tract

NCT02632019

Phase 1/2 Unknown 40 enrolled Second Military Medical University
RandomizedParallel-groupOpen-labelTreatment

Summary

Objectives: The purpose of this study is to evaluate the safety and prognosis of dendritic cell-precision T cell for neo-antigen in the treatment of advanced biliary tract malignant tumor. Methods: This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 40 patients will be enrolled. They are randomly divided into gemcitabine group and dendritic cell-precision T cell for neo-antigen combined with gemcitabine group. Gemcitabine treatments will be performed once a week with a total of six times. Dendritic cell-precision T cell for neo-antigen combined with gemcitabine treatment: Gemcitabine: once a week with a total of six times before 60 days prior to the start of drawing blood. Dendritic cell-precision T cell for neo-antigen: once per 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.

Timeline

Start
2015-09
Primary completion
2017-03
Completion
2017-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dendritic Cell Cell therapy 1e+07 cells Subcutaneous
Subject PNAT Cell therapy 1e+09 cells Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications