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

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease
• Graft vs Host Disease

• 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