Treatment Using CD45RA-Depleted Donor Immune Cells for Persistent Viral Infections After Stem Cell Transplant A Multicenter Single-Group Phase 12 Study

What this Trial Is About

This research aims to evaluate whether giving patients special donor immune cells called CD45RA Depleted Donor Lymphocyte Infusion DLI can help treat viral infections that do not improve with standard antiviral drugs after a stem cell transplant. The study focuses on patients who remain immunocompromised after transplantation and are vulnerable to infections, a leading cause of death. It also aims to assess the safety of this treatment and its effects on immune recovery. Participants will receive CD45RA Depleted DLI using the CliniMACS system, which selectively removes naive T cells from donor lymphocytes while keeping memory T cells. This approach is intended to promote immune recovery, clear persistent viral infections, and reduce the risk of graft-versus-host disease GVHD. The study is a prospective, multicenter, single-arm trial where all participants receive this treatment, with doses escalated as needed. During the trial, participants will be monitored for viral infection response using quantitative PCR and clinical criteria at 90 days after the first infusion. Researchers will also evaluate virus-specific T cell immunity and monitor for acute and chronic GVHD up to one year. Participants will undergo laboratory tests, clinical assessments, and follow-up visits to track safety and immune recovery throughout the study period.

CD45RA-depleted DLI for the Treatment of Refractory/Persistent Viral Infections After Haploidentical Transplantation