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NCT Number: NCT06364319

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

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.

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Key information

Conditions

cGVHD

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

anti-CD25 rhMAb

Drug

1 mg/kg/day administered IV day 1, 4, and 8, then weekly for 6 doses. For patients achieving partial remission, an extra dose of Anti-CD25 rhMAb can be given on days 39 and 49.

Prednisone

Drug

Maintain pre-screening dose

Ruxolitinib

Drug

10mg, BID PO

cyclosporine

Drug

1.25mg/kg, BID PO/IV, target:150-250ng/ml

Primary outcomes

  1. overall response rate (ORR)

    Time frame: 56 days

    ORR is defined as the percentage of complete response (CR) and partial response (PR).

Secondary outcomes

  1. duration of response（DOR）

    Time frame: 1 year

    DOR is defined as the duration calculated from the time of achieving PR or CR until the progression of GVHD, the addition of other systemic immunosuppressive therapy, or death.

  2. patient-reported outcomes (PRO)

    Time frame: 1 year

    the unabbreviated scale title is the Lee Chronic GVHD Symptom Scale.the minimum and maximum are 0 and 100, and higher scores mean a worse outcome.

  3. disease-free survival (DFS)

    Time frame: 1 year

    DFS is defined as the duration of survival after treatment in which the original hematologic disease is in a state of complete remission.

  4. failure-free survival (FFS)

    Time frame: 1 year

    Events that are considered as failures include the onset of new chronic GVHD, relapse, and death.

  5. non-relapse mortality (NRM)

    Time frame: 1 year

    NRM is defined as death due to reasons other than progression/relapse of hematologic disease.

  6. overall survival （OS）

    Time frame: 1 year

    OS is defined as the time from treatment until death from any cause or the last follow-up.

  7. adverse drug reactions (ADR)

    Time frame: 1 year

    The occurrence of various organ toxicities related to treatment that emerge following treatment.

  8. Best Overall Response Rate (ORR) of Overall cGVHD

    Time frame: 1 year

    CR + PR Rate of Overall cGVHD

  9. Immune Reconstitution

    Time frame: 1 year

    Humoral immune reconstitution (IgM, IgA, and IgG)；Cellular immune reconstitution parameters (CD3⁺, CD4⁺, CD8⁺, and CD19⁺ cell subsets)

  10. Quality of Life Assessment

    Time frame: 1 year

    SF-36 Questionnaire；FACT-BMT Questionnaire

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 15, 2024
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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