NCT05823675

Safety and Clinical Activity of Itolizumab in aGVHD

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Biotech Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Acute Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Itolizumab	Subjects will receive Itolizumab concomitant within 72 hours of systematic Corticosteroids.
DRUG	Methylprednisolone	Methylprednisolone will be taperred as required

Timeline

• Start date: 2023-05-19
• Primary completion: 2024-10-01
• Completion: 2025-02-01
• First posted: 2023-04-21
• Last updated: 2023-05-25

Locations

1 site across 1 country: China