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

Sponsor
Peking University People's Hospital
Study ID
NCT06364319
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Apr 15, 2024
Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-CD25 rhMAb + traditional therapy

Primary Outcome Measure

overall response rate (ORR) [ Time Frame: 56 days ]

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