Phase III Study of Memory T Cell Donor Lymphocyte Infusions After Transplantation of TCR and CD19 Depleted Stem Cells From Haploidentical Donors for Blood Cancer Treatment

What this Trial Is About

This clinical trial focuses on patients with hematologic malignancies who have undergone transplantation using T-cell receptor alphabeta TCRb1b2 and CD19 depleted peripheral blood stem cells from haploidentical donors. The purpose is to study the safety and toxicity of donor lymphocyte infusions DLI depleted of CD45RA lymphocytes, following this transplantation. The trial includes both a dose-finding phase phase I and a confirmatory extension phase phase II to establish the maximum tolerated dose of the memory T cell DLI. Patients first receive a standard reduced intensity conditioning regimen followed by an intravenous infusion of TCRb1b2CD19 depleted stem cells, which is not part of the trial treatment. If patients do not develop graft-versus-host disease GVHD, they receive the study-related CD45RA depleted memory T cell donor lymphocyte infusion approximately 30 days after transplantation. The phase I dose escalation part enrolls patients in cohorts of three with up to three dose levels, and a potential lower dose level if higher doses cause severe GVHD. Phase II uses the maximum tolerated dose identified to further evaluate the treatment. Participants will be closely monitored for safety and toxicity during the first 100 days after infusion in both phases. Assessments include clinical evaluations and laboratory tests to detect any adverse effects or graft-versus-host disease. The total duration of participant involvement covers these 100-day periods post-infusion, during which the primary outcomes related to dose escalation and treatment safety are measured. This study is sponsored by the University Hospital Tuebingen and includes both adult and pediatric patients aged 8 weeks to 65 years.

CD45RA Depleted DLI After TCRα/β Depleted Haploidentical HCT