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

Study on the Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease (cGVHD) of the Liver Following Allogeneic Hematopoietic Stem Cell Transplantation.

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.

Inclusion Criteria:

1. Age 16 and 65 years
2. Received allogeneic hematopoietic stem cell transplantation
3. Developed chronic GVHD in the liver after transplantation
4. Ineffective prednisone treatment prior to screening
5. Received ≤4 lines of systemic therapy prior to screening
6. After informed consent, the patient agreed to receive anti-CD25 rhMAb treatment

Exclusion Criteria:

1. Elevation of bilirubin, ALT, or alkaline phosphatase due to reasons other than chronic GVHD
2. No prior treatment with prednisone
3. Overlap syndrome
4. Uncontrolled active infection
5. Organ failure
6. Early progression or recurrence of hematologic diseases
7. Allergy to anti-CD25 rhMAb
8. Received other interleukin-2 receptor monoclonal antibody treatment due to various reasons within one month after transplantation
9. Participated in other clinical studies within one month