The purpose of this study is to determine the maximum tolerated dose and evaluate the safety of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem cell transplant from a related, haploidentical donor, 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
19
Single intravenous infusion
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Dose limiting toxicity, defined as acute graft-versus-host disease grade III or IV
Time frame: Within 30 days after ATIR infusion
Immune reconstitution
Time frame: Until 60 months after ATIR infusion
Rate of disease relapse
Time frame: Until 60 months after ATIR infusion
Occurrence and severity of graft-versus-host disease
Time frame: Until 60 months after ATIR infusion
Occurrence of adverse drug reactions
Time frame: Until 18 months after ATIR infusion
Incidence and severity of infections
Time frame: Until 18 months after ATIR infusion
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