Phase IIb Study of BPC2001 With Standard Treatment to Prevent Acute Graft-Versus-Host Disease After Haploidentical Stem Cell Transplantation

What this Trial Is About

Researchers are evaluating the safety and effectiveness of repeated doses of BPC2001 combined with standard care to prevent acute graft-versus-host disease aGvHD in patients who have undergone haploidentical stem cell transplantation Haplo-SCT. This Phase IIb open-label study aims to understand how well BPC2001 works alongside current treatments in this specific transplant setting. Participants will receive six weekly intravenous doses of BPC2001 at approximately 100 micrograms per kilogram, following the completion of Haplo-SCT. The study begins with a Safety Run-in Phase involving small groups to assess safety and tolerability over 30 days after the first dose. After determining a safe dose, the Expansion Phase will enroll more subjects to evaluate the efficacy of the six-dose regimen combined with standard GvHD prevention treatments. During the study, participants will be closely monitored with laboratory tests, vital sign checks, and assessments of graft function for up to one year after transplantation. Researchers will measure the occurrence of aGvHD grades II-IV by day 100, along with adverse events and serious adverse events related to BPC2001, as well as pharmacokinetic profiles after dosing. Secondary outcomes include long-term survival rates, chronic GvHD incidence, and disease-free survival at 180 days and one year post-transplant.

BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation