OncoMatch/Clinical Trials/NCT04318678
CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)
Is NCT04318678 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for aml/mds.
Treatment: Cyclophosphamide · Fludarabine · Mesna · Rituximab · CD123-CAR T — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: IL3RA expression (CD123 positive)
Relapsed/refractory CD123+ disease defined as follows:
Required: CD19 negative/dim (negative/dim)
CD19 negative/dim or patients otherwise ineligible for CD19 directed therapies
Prior therapy
Must have received: induction chemotherapy — AML/MDS refractory: not achieving CR after 2 cycles
Patients not achieving a CR after 2 cycles of induction chemotherapy
Must have received: allogeneic HSCT — B-cell ALL: relapse after allogeneic HSCT
Patients with relapse after allogeneic HSCT
Must have received: front-line therapy — BPDCN: relapsed/refractory disease that has failed front-line therapy
BPDCN • Relapsed/refractory disease that has failed front-line therapy
Cannot have received: donor lymphocyte infusion
Exception: within the 28 days prior to apheresis or planned infusion
have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis/planned infusion
Cannot have received: systemic steroids
Exception: exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, in the 7 days prior to CD123-CAR T-cell infusion
Receiving systemic steroids therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, in the 7 days prior to CD123-CAR T-cell infusion
Cannot have received: systemic therapy
Exception: in the 14 days prior to CD123-CAR T-cell infusion, which will interfere with the activity of the CD123-CAR T cells in vivo (in the opinion of the study PI(s))
Receiving systemic therapy in the 14 days prior to CD123-CAR T-cell infusion, which will interfere with the activity of the CD123-CAR T cells in vivo (in the opinion of the study PI(s))
Cannot have received: rituximab (rituximab)
Exception: in the 30 days prior to CD123-CAR T cell infusion
Receiving rituximab therapy in the 30 days prior to CD123-CAR T cell infusion
Cannot have received: intrathecal chemotherapy
Exception: in the 7 days prior to CD123-CAR T cell infusion
Receiving intrathecal chemotherapy in the 7 days prior to CD123-CAR T cell infusion
Lab requirements
Kidney function
creatinine clearance or radioisotope GFR ≥50 ml/min/1.73m2 (GFR ≥40 ml/min/1.73m2 if < 2 years of age)
Liver function
Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome; ALT or AST ≤5 times the upper limit of normal for age
Cardiac function
left ventricular ejection fraction >40%, OR shortening fraction ≥25%; EKG without evidence of clinically significant arrhythmia
Adequate cardiac function defined as left ventricular ejection fraction >40%, OR shortening fraction ≥25%; EKG without evidence of clinically significant arrhythmia; Adequate renal function defined as creatinine clearance or radioisotope GFR ≥50 ml/min/1.73m2 (GFR ≥40 ml/min/1.73m2 if < 2 years of age); Adequate pulmonary function defined as forced vital capacity (FVC)≥50% of predicted value; or pulse oximetry≥92% on room air if patient is unable to perform pulmonary function testing; Total Bilirubin≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome; Alanine aminotransferase (ALT) OR aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St Jude Children's Research Hospital · Memphis, Tennessee
- St. Jude Children's Research Hospital · Memphis, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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