Phase I Study of Prophylactic TCRαβ+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies
University of Wisconsin, Madison
Summary
This study is being done to assess the safety and determine the maximum tolerable dose (MTD) of TCRαβ+/CD19+-depleted Donor Lymphocyte Infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in highrisk patients with hematologic malignancies.
Description
Primary Objectives * To assess safety of prophylactic TCRαβ+/CD19+ depleted donor lymphocyte infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in high-risk patients with hematologic malignancies * To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of αβT/B dep-DLI Secondary Objectives * To assess the feasibility of αβT/B dep-DLI * To assess additional safety parameters after αβT/B dep-DLI * To assess the efficacy of αβT/B dep-DLI For the dose escalation phase: Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD) is defined a…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with high-risk myeloid or lymphoid malignancies determined to be eligible to undergo allo-SCT including but not limited to the conditions listed below. These criteria apply at the disease diagnosis or any time prior to the cyto-reductive therapy given before the planned conditioning: * Refractory acute myelogenous (AML) or lymphoid leukemia (ALL) * Relapsed AML or ALL * AML in European LeukemiaNet (ELN) high risk per cytogenetic and mutation * Any patients with minimal residual disease (MRD+) disease by flow cytometry or with active disease (not in comp…
Interventions
- DeviceAllogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
Single intravenous dose of allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells (i.e., αβT/B dep-DLI), where the dose is based on the natural killer (NK) cell (CD3-CD56+) content in the DLI product. Each participant will receive one of four DLI doses depending upon cohort to which the participant is enrolled.
Location
- UW Carbone Cancer CenterMadison, Wisconsin