drugset / Trial / NCT02659800

Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas

NCT02659800

RandomizedParallel-groupDouble-blindSupportive care

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) and select optimal biological doses (OBD) of the study drug NT-I7 in High Grade Glioma patients with severe lymphopenia, as well as to test the effect of NT-I7 on the CD4 counts of patients in comparison to control participants. This study has both a Phase I and Pilot component.

Timeline

Start
2018-10-30
Primary completion
2022-03-30
Completion
2023-10-03

Drugs

EvaluationDrugModalityDoseRoute
Subject NT-I7 Protein / enzyme biologic 60 ug/kg Intramuscular