CD123-Directed Autologous T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)

2020-03-27 03:25:33 | BioPortfolio


The CD123+ CAR therapy is a new treatment that is being investigated for treatment of AML. The purpose of this study is to find the maximum (highest) dose of CD123+ CAR cells that is safe to give patients with AML. This would include studying the side effects of the chemotherapy, as well as the CD123+ CAR 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+ AML 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 AML blasts post CD123-CAR T-cell therapy


This study will evaluate the safety and maximum tolerated dose of CD123-CAR T cells.

This study contains 2 phases.The first part is the called the "Collection and Manufacturing Phase" and the second is the "Treatment Phase".

The Collection and Manufacturing Phase refers to your blood cells being collected and possibly frozen, via a process called apheresis. These cells will then be changed to improve their ability to recognize and kill cancer cells.

The Treatment Phase refers to the portion of the study in which you receive an infusion of the CD123+ CAR cells that were made in the Collection and Manufacturing Phase; chemotherapy is often given for several days prior to the cellular infusion. You are then monitored for any possible side effects.

Chemotherapy is typically given to get your body ready to accept the CATCHAML treatment.

Treatment Schedule:

Patients will receive lymphodepleting chemotherapy followed by infusion of CD123-CAR T cells

Fludarabine on day -4, -3 and -2

Cyclophosphamide on day -2

REST DAY on day -1

CD123+CAR cell infusion on day 0 or +1

Study Design


Acute Myeloid Leukemia


CD123-CAR T, Cyclophosphamide, Fludarabine, Mesna, Rituximab


St. Jude Children's Hospital
United States


Not yet recruiting


St. Jude Children's Research Hospital

Results (where available)

View Results


Published on BioPortfolio: 2020-03-27T03:25:33-0400

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Medical and Biotech [MESH] Definitions

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Clonal expansion of myeloid blasts in bone marrow, blood, and other tissue. Myeloid leukemias develop from changes in cells that normally produce NEUTROPHILS; BASOPHILS; EOSINOPHILS; and MONOCYTES.

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