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

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 escala

Trial Details

NCT ID

NCT04318678

Phase

PHASE1

Sponsor

St. Jude Children's Research Hospital

Status

RECRUITING

Cancer Type

Leukemia

Interventions

CD123-CAR T
Cyclophosphamide
Fludarabine
Mesna
Rituximab

Locations (sample)

Memphis, Tennessee, United States|35.14953,-90.04898
Memphis, Tennessee, United States|35.14953,-90.04898

Key Eligibility Criteria

Age ≤21 years old
Relapsed/refractory CD123+ disease defined as follows:
Relapsed disease: Patients developing recurrent disease after a first complete remission (CR)
Refractory disease: Patients not achieving a CR after 2 cycles of induction chemotherapy

For full eligibility, visit ClinicalTrials.gov.

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