48
Participants
Start Date
November 12, 2024
Primary Completion Date
October 30, 2029
Study Completion Date
October 30, 2029
recombinant humanized anti-CD25 monoclonal antibody
"For children at high risk of GVHD, one of the following conditions must be met (haploidentical donors must meet one condition, while unrelated donors must meet two conditions):~1. The donor is ≥40 years old;~2. The donor is an unrelated donor with ≥1 locus mismatch, a haploidentical female donor, or collateral consanguinity (e.g., cousin, uncle/aunt);~3. Pre-transplant CD3 count ≥4 x 10\^8/kg;~4. The primary disease is in an HLH (hemophagocytic lymphohistiocytosis) flare or active disease phase;~5. ATG (or biologically equivalent doses of ATLG \[1:2\] or ALG \[1:20\]) \<10mg/kg. Combining recombinant anti-CD25 humanized monoclonal antibody with conventional pretreatment regimen, before peripheral blood stem cell transfusion (i.e. 0d) and+3d, 1mg/kg,\<40kg the maximum dose should not exceed25mg/dose, ≥40kg 1mg/kg, and the maximum dose should not exceed 50mg/dose."
RECRUITING
Beijing Children's Hospital Capital Medical University, Beijing
Beijing Children's Hospital
OTHER