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

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Apr 12, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Anti-CD25 rhMAb for patients with a condition known as steroid-refractory chronic graft-versus-host disease (cGVHD) that affects the liver after receiving a stem cell transplant. In simple terms, cGVHD can happen when the new immune cells from the donor attack the recipient's body, leading to various complications. The study will compare the effects of this new treatment to traditional therapies to see which works better and is safer for patients.

To participate in this trial, patients need to be between the ages of 16 and 65, have had a stem cell transplant, and have experienced liver cGVHD that has not responded to standard steroid treatment. They should not have had more than four other treatments for this condition before joining the study. If eligible, participants will receive either the new treatment or standard care after giving their consent. It’s important to note that the trial is not yet recruiting participants, so there’s still time to learn more before deciding to take part.

Gender

ALL

Eligibility criteria

• 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