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

GVHD, Chronic Clinical Trial

Official title:
A Multicenter, Open Phase Ib/II Study of TDI01 Suspension in the Treatment of Glucocorticoid-resistant/Dependent Moderate-to-severe Chronic Graft-versus-host Disease (cGVHD))

Status Not yet recruiting

Clinical Trial 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

Clinical Trial Description

1. Phase Ib study stage: Primary objective: To evaluate the efficacy and safety of TDI01 suspension in treating patients with moderate to severe cGVHD who are resistant to/dependent on glucocorticoids. Secondary objectives: To evaluate the population pharmacokinetic characteristics of TDI01 suspension in treating patients with moderate to severe cGVHD who are resistant to/dependent on glucocorticoids. 2. Phase II study stage: Primary objective: To evaluate the efficacy of TDI01 suspension in treating patients with moderate to severe cGVHD who are resistant to/dependent on glucocorticoids. Secondary objectives: To evaluate the safety of TDI01 suspension in treating patients with moderate to severe cGVHD who are resistant to/dependent on glucocorticoids, as well as the population pharmacokinetic characteristics of TDI01 suspension in treating these patients. ;

Study Design

Related Conditions & MeSH terms

Bronchiolitis Obliterans Syndrome
Graft vs Host Disease
GVHD, Chronic

Clinical Trial Details

NCT number	NCT06169722
Study type	Interventional
Source	Beijing Tide Pharmaceutical Co., Ltd
Contact
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	January 2024
Completion date	August 2027

View Details

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