drugset / Trial / NCT05604742

Belimumab for Treatment of cGVHD Following Allo-HCT

NCT05604742

Phase 1/2 Withdrawn xuna
RandomizedParallel-groupSingle-blindTreatment

Summary

Given the role of B cells in the pathophysiology of chronic graft versus host disease (GvHD), the association between elevated BAFF levels post-transplant in abnormal B-cell homeostasis and chronic GvHD, and the efficacy of belimumab in the inhibition of soluble human B lymphocyte stimulator protein (BAFF) signaling, these proof-of-principle findings support the rational for use of belimumab as treatment of chronic GvHD.The investigators propose a pilot and feasibility study to assess the safety and tolerability, as well as preliminary efficacy, of belimumab a treatment of cGvHD following allogeneic hematopoietic cell transplantation (alloHCT). The investigators' central hypothesis is that belimumab will be well tolerated and have a favorable effect on chronic GvHD,and we explored therapeutic dosage of belimumab.

Timeline

Start
2022-01-01
Primary completion
2024-12-30
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Belimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Belimumab Monoclonal antibody 4 mg/kg Intravenous