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Safety and Clinical Activity of Itolizumab in aGVHD

Acute Graft Versus Host Disease Clinical Trial

Official title:
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Itolizumab in Subjects With Newly Diagnosed Acute Graft Versus Host Disease

Clinical Trial Summary

To evaluate the safety, tolerability, PK, PD, and clinical activity of Itolizumab in subjects with Newly diagnosed Acute Graft Versus Host Disease(aGVHD).

Clinical Trial Description

The study will enroll approximately 44 subjects in three parts: Part 1 is an open label 3+3 single dose escalation phase and will enroll approximately 30 subjects with aGVHD across 4 cohorts, where subjects will receive Itolizumab administered intravenously for 1 dose. Part 2 is an open label phase and subjects from part 1 will receive Itolizumab administered intravenously every two weeks for a total of 4 doses. Part 3 is a randomized phase and will enroll approximately 14 additional subjects, randomized in a 1:1 ratio to one of the 2 recommended doses provided by Part 1 and Part 2. Subjects will receive Itolizumab administered intravenously every two weeks for a total of 5 doses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05823675
Study type Interventional
Source Biotech Pharmaceutical Co., Ltd.
Contact Xijuan Song
Phone 010-51571020
Email songxijuan@biotechplc.com
Status Recruiting
Phase Phase 1
Start date May 19, 2023
Completion date February 2025
View Details
See also
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