Feasibility Study of Alpha-Beta T-Cell Depletion Using CliniMACS Device in Stem Cell Transplant Patients up to Age 30

What this Trial Is About

Patients who need an allogeneic hematopoietic cell transplant HCT face the risk of developing graft-versus-host disease GVHD. To reduce this risk, one approach uses ex vivo alpha-beta T-cell depletion of donor cells. The CliniMACS Device, approved by the FDA for a limited use, can process these cells, but other uses require research protocols. This study explores the feasibility of using the CliniMACS system for alpha-beta T-cell depletion in stem cell transplant recipients to better understand its application beyond approved indications. The CliniMACS CD34 Reagent System uses antibodies linked to magnetic particles to select blood stem cells CD34 cells from donor samples. In this study, stem cell products depleted of alpha-beta T-cells using the CliniMACS system are infused intravenously at a rate based on body weight. The aim is to deliver a target dose of CD34 cells and minimize alpha-beta T-cell numbers to reduce the risk of GVHD. This approach also includes simultaneous depletion of CD19 B cells. The study evaluates this method as an alternative to traditional CD34-selection techniques. Participants will receive the alpha-beta T-cell depleted stem cell infusion and be monitored for outcomes including the incidence of severe acute GVHD within 100 days. Other assessments include engraftment success, transplant-related mortality, chronic GVHD requiring steroids, autoimmunity needing immunosuppressive treatment, and T-cell immune recovery over the first year after transplant. Safety and effectiveness of the procedure are followed up to one year, with the total participation duration varying accordingly.

A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant