Phase I, Dose-ranging, Open-label, Study of a Single Administration of T-cells Add-back Depleted of Host Alloreactive Cells Using Theralux™ Therapy, Following Haploidentical Peripheral Blood Stem Cell Transplantation Submitted to CD34+ Cell Selection, in Patients With Severe Hematologic Malignancies
Allogeneic stem cell transplantation is the treatment of choice for many patients with
leukemia and other hematologic malignancies. However, a major limitation of this therapy is
that for a significant number of patients no fully HLA-matched donor can be found. The
application of partially HLA-matched (haploidentical) family donors, who are virtually
always available, has some complications. If there is no T-cell add-back it increases the
risk for life-threatening infections and disease relapse, while in case of T-cell add-back
the risk of graft-versus-host disease is raised.
Kiadis Pharma has developed a method to selectively deplete host alloreactive T-cells
through photodynamic therapy, using TH9402 ex vivo. The donor lymphocyte preparation
depleted of functional alloreactive T-cells (ATIR) are administered to the patient 4-6 weeks
after the stem cell transplant. This method enables early immune reconstitution while
preventing graft-versus-host disease.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Dose limiting toxicity, defined as acute graft-versus-host disease grade III or IV
Within 30 days after ATIR infusion
Yes
Denis-Claude Roy, MD
Principal Investigator
Maisonneuve-Rosemont Hospital, Montréal, Canada
Canada: Health Canada
CR-GVH-001
NCT00993486
January 2005
April 2013
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