A Phase I Clinical Trial Assessing Prophylactic Donor CD45RA-depleted Lymphocyte Infusions Into Patients Transplanted with Stem Cell Grafts from Haploidentical Donors After Reduced Intensity Conditioning

What this Trial Is About

Researchers are evaluating the safety and feasibility of giving prophylactic CD45RA-negative memory/effector T lymphocyte infusions to patients who have undergone haploidentical stem cell transplantation with reduced intensity conditioning for hematologic malignancies. This phase 1 clinical trial focuses on preventing complications in the early post-transplant period by using donor lymphocytes depleted of naive T cells. Participants receive up to three intravenous infusions of escalating doses of CD45RA-negative cells, which are isolated from the original donor through leukapheresis and prepared using CliniMACS® technology. These infusions are given at intervals of 6 to 8 weeks, starting at least 4 weeks after transplantation if graft-versus-host disease (GvHD) is absent. The cells are stored in vapor nitrogen until administration. During the study, participants are closely monitored for safety outcomes including acute transfusion reactions within 24 hours after each infusion and acute GvHD grade II-IV within 8 weeks post-infusion. Researchers will assess feasibility and safety through clinical evaluations and laboratory tests. The total participation period includes multiple infusions and follow-up to track adverse events and transplant complications.

Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC