Actively Recruiting
CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia and Related Blood Cancers (CATCHAML)
Led by St. Jude Children's Research Hospital · Updated on 2026-05-19
108
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying CD123-CAR T-cell therapy as a new treatment for patients 21 years old or younger with certain blood cancers, including acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), T- or B-cell acute lymphoblastic leukemia (ALL), and blastic plasmacytoid dendritic cell neoplasia (BPDCN). The main goal is to find the highest safe dose of these modified immune cells after chemotherapy, while monitoring side effects and overall patient survival. This is a phase 1 trial sponsored by St. Jude Children's Research Hospital. The study has two main parts: first, blood cells are collected from patients and modified in the lab to better target cancer cells. Then, patients receive chemotherapy called lymphodepleting chemotherapy for several days to prepare their body for the treatment. This includes fludarabine given on days -4, -3, and -2 and cyclophosphamide on days -3 and -2. After a rest day on day -1, patients receive one infusion of the CD123-CAR T cells on day 0 or day +1. The trial tests up to four dose levels of the CAR T cells, with special groups for patients with or without a transplant donor. Participants will have blood drawn for cell collection and then receive chemotherapy and the CAR T-cell infusion under close medical supervision. They will be monitored for side effects, and their disease status will be regularly evaluated. Safety and maximum tolerated dose will be assessed four weeks after infusion. Other tests include monitoring immune cell profiles, tumor changes, and comparing donor-derived to autologous CAR T cells. The total involvement lasts through treatment and follow-up to measure safety and disease response.
CONDITIONS
Brief 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
- Diagnosed with relapsed or refractory CD123-positive AML, MDS, B-ALL, T-ALL, or BPDCN
- Estimated life expectancy greater than 8 to 12 weeks depending on study phase
- Karnofsky or Lansky performance score of 50 or higher
- Clinically recovered from prior allogeneic hematopoietic cell transplant (HCT) with no active graft-versus-host disease and no donor lymphocyte infusion within 28 days before apheresis or infusion
- Identified suitable hematopoietic cell transplant (HCT) donor
- Adequate cardiac, renal, and pulmonary function as defined by study
- Negative pregnancy test within 7 days prior to enrollment for females of child-bearing age
- Agreement to use birth control until 3 months after T-cell infusion if sexually active
- Available autologous transduced T-cell product that meets manufacturing standards
You will not qualify if you...
- Known primary immunodeficiency
- History of HIV infection
- Severe uncontrolled bacterial, viral, or fungal infection including active hepatitis B or C
- History of hypersensitivity reactions to murine protein-containing products
- History of severe hypersensitivity to cornstarch or hydroxyethyl starch
- Receiving systemic steroids above 0.5 mg/kg/day methylprednisolone within 7 days prior to infusion
- Receiving systemic therapy within 14 days prior to infusion that may interfere with CD123-CAR T cells
- Receiving rituximab therapy within 30 days prior to infusion
- Receiving intrathecal chemotherapy within 7 days prior to infusion
- Known contraindication to lymphodepleting chemotherapy regimen (fludarabine/cyclophosphamide)
- Active central nervous system disease
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies depending on cell collection and manufacturing process
Participants have their blood cells collected via apheresis to create CD123-CAR T cells that can recognize and attack cancer cells.
1 to 2 visits for blood cell collection
Duration - Approximately 1 week including chemotherapy and infusion
Participants receive lymphodepleting chemotherapy for several days to prepare for the CD123-CAR T cell infusion, followed by the infusion of the CD123-CAR T cells.
Daily visits for chemotherapy on days -4, -3, and -2, rest day on day -1, and infusion visit on day 0 or +1
Duration - At least 4 weeks after infusion
Participants are monitored for side effects and safety after the CD123-CAR T cell infusion.
Multiple follow-up visits during the 4 weeks post-infusion
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
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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