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NCT04318678 · ClinicalTrials.gov registry record · Phase 1
CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)
A Phase 1 study of B-ALL and AML/MDS, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
- 2
- Study locations
NCT04318678: Recruiting Phase 1 study of B-ALL and AML/MDS, sponsored by St. Jude Children's Research Hospital.
NCT04318678 is a Phase 1 study of B-ALL and AML/MDS that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 108 participants, above the 72-participant average among 7 other B-ALL trials with a reported enrollment target (50% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04318678, a Phase 1 study of B-ALL and AML/MDS, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
- 2
- Study locations
Study 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
Primary Outcome
A phase I design to determine the maximum tolerated dose (MTD) of autologous, CD123- CAR T cells. Four dose levels (3x10\^5/kg, 1x10\^6/kg, 3x10\^6/kg, and 1x10\^7/kg) will be evaluated.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG CD123-CAR T
- DRUG Mesna
- DRUG Rituximab
Study Locations (2)
Tennessee
- St Jude Children's Research Hospital - Memphis
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2030-07-29 |
| Phase | Phase 1 |
What NCT04318678 shows while recruiting
NCT04318678 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, above the 72-participant average among 7 other B-ALL trials with a reported enrollment target (50% higher).
The record links to 4 conditions, with B-ALL appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04318678 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04318678 about?
NCT04318678 is a clinical study titled "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 CD1...
What is the current status of trial NCT04318678?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2020-07-29. Estimated completion is 2030-07-29.
What conditions does trial NCT04318678 study?
This clinical trial studies the following conditions: B-ALL, AML/MDS, BPDCN, T-ALL.
What interventions are being tested in trial NCT04318678?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), CD123-CAR T (DRUG), Mesna (DRUG), Rituximab (DRUG).
Who is sponsoring clinical trial NCT04318678?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04318678 being conducted?
This trial has 2 study locations across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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