CD123-Directed Autologous T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)
Status:
Recruiting
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
Summary
The CD123-CAR T-cell therapy is a new treatment that is being investigated for treatment of
AML, T-ALL, B-ALL or BPDCN. The purpose of this study is to find the maximum (highest) dose
of CD123-CAR T cells that is safe to give to these patients. This would include studying the
side effects of the chemotherapy, as well as the CD123-CAR T-cell product on the recipient's
body, disease and overall survival.
Primary Objective
To determine the safety of one intravenous infusion of escalating doses of autologous,
CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML,
B-ALL, T-ALL or BPDCN) after lymphodepleting chemotherapy.
Secondary Objectives
To evaluate the antileukemia activity of CD123-CAR T cells.
Exploratory Objectives
- To assess the immunophenotype, clonal structure and endogenous repertoire of CD123-CAR T
cells and unmodified T cells
- To characterize the cytokine profile in the peripheral blood and CSF after treatment
with CD123-CAR T cells
- To characterize tumor cells post CD123-CAR T-cell therapy