RecruitingPhase 1NCT04318678

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


Sponsor

St. Jude Children's Research Hospital

Enrollment

108 participants

Start Date

Jul 29, 2020

Study Type

INTERVENTIONAL

Conditions

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. * To determine the safety of an intravenous infusion of escalating doses of donor derived, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML/MDS, B-ALL, T-ALL, BPDCN or MPAL) 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 * To compare in vivo properties of donor-derived versus autologous CD123- CAR T cells


Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized immune therapy called CAR-T cell therapy that is engineered to attack cancer cells carrying a protein called CD123 in children and young adults with leukemia or related blood cancers that have come back or not responded to prior treatment. **You may be eligible if...** - You are 21 years old or younger - You have one of the following relapsed or treatment-resistant blood cancers: AML (acute myeloid leukemia), MDS (myelodysplastic syndrome), B-cell ALL (CD123 positive, CD19 negative), T-cell ALL, or BPDCN - Your cancer has come back after treatment or has not responded to at least 2 cycles of chemotherapy - Your life expectancy is at least 12 weeks - Your organ function is adequate **You may NOT be eligible if...** - You have active, uncontrolled infection - You have significant organ failure - You are pregnant or breastfeeding - You have had prior CAR-T therapy targeting CD123 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCD123-CAR T

To treat relapsed/refractory CD123+ AML/MDS, B-ALL, T-ALL or BPDCN patient population that needs new cancer-directed therapies.

DRUGCyclophosphamide

Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.

DRUGFludarabine

Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis

DRUGMesna

Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide

DRUGRituximab

Rituximab is a monoclonal antibody directed against the CD20 antigen on the surface of B-lymphocytes


Locations(2)

St Jude Children's Research Hospital

Memphis, Tennessee, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

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NCT04318678


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