Actively Recruiting
CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)
Led by St. Jude Children's Research Hospital · Updated on 2026-03-30
108
Participants Needed
2
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or younger
- Relapsed or refractory CD123-positive AML/MDS, B-ALL, T-ALL, or BPDCN
- Relapsed AML/MDS after first complete remission or refractory disease after 2 induction chemotherapy cycles
- Relapsed or refractory CD123-positive B-ALL that is CD19 negative/dim or unsuitable for CD19 therapies
- Relapsed or refractory CD123-positive T-ALL
- Relapsed or refractory BPDCN after front-line therapy failure
- Estimated life expectancy greater than 12 weeks (for procurement phase) or greater than 8 weeks (for treatment phase)
- Karnofsky or Lansky performance score of 50 or higher
- Clinically recovered from prior allogeneic stem cell transplant with no active graft-versus-host disease and no donor lymphocyte infusion within 28 days prior to apheresis or infusion
- Identified suitable hematopoietic cell transplant donor
- For females of child-bearing age: not pregnant, not lactating, with negative pregnancy test within 7 days prior to enrollment
- Eligible for or have completed autologous apheresis
- Detectable CD123-positive disease at treatment start
- Adequate cardiac, renal, and pulmonary function as defined in the protocol
- Recovered from significant non-hematologic toxicities from previous therapies
- Agreement to use birth control if sexually active until 3 months after T-cell infusion
You will not qualify if you...
- Known primary immunodeficiency
- History of HIV infection
- Severe uncontrolled bacterial, viral, or fungal infection
- History of hypersensitivity to murine protein-containing products
- Acute promyelocytic leukemia (APL, t(15;17))
- Contraindication to lymphodepleting chemotherapy with fludarabine and cyclophosphamide
- History of severe hypersensitivity to cornstarch or hydroxyethyl starch
- Receiving systemic steroids above 0.5 mg/kg/day methylprednisolone equivalent within 7 days before infusion
- Receiving systemic therapy within 14 days before infusion that may interfere with CD123-CAR T cells
- Receiving rituximab within 30 days before infusion
- Receiving intrathecal chemotherapy within 7 days before infusion
- Active central nervous system disease
AI-Screening
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Trial Site Locations
Total: 2 locations
1
St Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
2
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
S
Swati Naik, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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