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

NCT06169722 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-26

No results posted yet for this study

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

Conditions

  • GVHD, Chronic

Interventions

DRUG

TDI01 suspension

200mg or 400mg oral once a day

Sponsors & Collaborators

  • Beijing Tide Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-06
Primary Completion
2026-02-28
Completion
2027-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06169722 on ClinicalTrials.gov