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

B-ALL Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

The CD123-CAR T-cell therapy is a new treatment that is being investigated for treatment of AML/myelodysplastic syndrome (MDS), T- or B- acute lymphoblastic leukemia (ALL) or blastic plasmacytoid dendritic cell neoplasia (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/MDS, 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

Clinical Trial Description

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 T cells that were made in the Collection and Manufacturing Phase; chemotherapy is given for several days prior to the cellular infusion. You are then monitored for any possible side effects.

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Chemotherapy is 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 -3 and -2

REST DAY on day -1

CD123-CAR T cell infusion on day 0 or +1 ;

Related Conditions & MeSH terms

• AML/MDS
• B-ALL
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• T-ALL

• NCT number: NCT04318678
• Study type: Interventional
• Source: St. Jude Children's Research Hospital
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 29, 2020
• Completion date: July 1, 2025