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Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD

StatusNot Yet Recruiting
PhasePhase 4
Started2026-07-15
View on ClinicalTrials.gov ↗

Amendment history

2026-06-16
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures v1
Start date2024-04-15→2026-07-15
Enrollment target118→30
Study arms2→1
Secondary endpoints7 to 10 entries
Best Overall Response Rate (ORR) of Overall cGVHD Immune Reconstitution Quality of Life Assessment
2024-04-12
Original filing
The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will receive a treatment regimen consisting of the Anti-CD25 rhMAb in combination with prednisone, cyclosporine, and ruxolitinib.The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver.
Trial Details
NCT Number NCT06364319
Lead Sponsor Peking University People's Hospital
Conditions cGVHD
Enrollment 30 participants
Start Date 2026-07-15
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-18