NCT06169722

TDI01 Suspension in the Treatment of Chronic Graft-versus-host Disease (cGVHD))

TDI01 for Treatment of Moderate or Severe Chronic Graft-Versus-Host Disease After Failure of at Least 1 and Not More Than 5 Lines of Systemic Therapy: an Open Label, Multi-center, ph1/2 Study

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing Tide Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

1. Phase Ib study stage: Primary objective: To evaluate the efficacy and safety Secondary objectives: To evaluate the population pharmacokinetic characteristics 2. Phase II study stage: Primary objective: To evaluate the efficacy Secondary objectives: To evaluate the safety

Detailed description

1. Phase Ib study stage: Primary objective: To evaluate the efficacy and safety of TDI01 suspension in treating patients with moderate or severe Chronic Graft-Versus-Host Disease after failure of at least 1 and not more than 5 lines of systemic therapy Secondary objectives: To evaluate the population pharmacokinetic characteristics of TDI01 suspension in treating patients with moderate or severe Chronic Graft-Versus-Host Disease after failure of at least 1 and not more than 5 lines of systemic therapy. 2. Phase II study stage: Primary objective: To evaluate the efficacy of TDI01 suspension in treating patients with moderate or severe Chronic Graft-Versus-Host Disease after failure of at least 1 and not more than 5 lines of systemic therapy Secondary objectives: To evaluate the safety of TDI01 suspension in treating patients withmoderate or severe Chronic Graft-Versus-Host Disease after failure of at least 1 and not more than 5 lines of systemic therapy as well as the population pharmacokinetic characteristics of TDI01 suspension in treating these patients.

Conditions

• GVHD, Chronic

Interventions

Type	Name	Description
DRUG	TDI01 suspension	200mg or 400mg oral once a day

Timeline

• Start date: 2024-02-06
• Primary completion: 2026-02-01
• Completion: 2027-08-01
• First posted: 2023-12-13
• Last updated: 2025-09-26

Locations

1 site across 1 country: China