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NCT05503134 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Expanded, Universal Donor Natural Killer Cells for Relapsed/Refractory AML
A Phase 1 study of Acute Myeloid Leukemia, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05503134: Recruiting Phase 1 study of Acute Myeloid Leukemia, sponsored by Nationwide Children's Hospital.
NCT05503134 is a Phase 1 study of Acute Myeloid Leukemia that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 20 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05503134, a Phase 1 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I/II dose escalation study designed to determine the safety and estimate the efficacy of UD-NK cells combined with FLA chemotherapy in patients age 1-24.99 with relapsed or refractory acute myeloid leukemia. PRIMARY OBJECTIVE: I. To determine the safety and recommended phase II dose of adoptive NK cell therapy using UD-NK cells in pediatric and young adult patients with relapsed/refractory AML. SECONDARY OBJECTIVES: I. To estimate the efficacy of UD- NK cells with FLA chemotherapy in pediatric and young adult patients with relapsed/refractory AML. EXPLORATORY OBJECTIVES: I. To determine the immunophenotype and function of UD-NK cells II. To characterize in vivo expansion of UD-NK cells III. To determine the persistence of UD-NK cells Six doses of universal donor mbIL-21 expanded NK cells (UD-NK) given thrice weekly for two weeks. Days may vary and NK cells can be given from days 0 to 21. Patients may receive up to 2 cycles of fludarabine/cytarabine (FLA) + NK cells (up to 12 NK cell infusions) if they do not achieve CR after cycle 1 or if necessary to bridge to transplant.
Conditions Studied
Interventions
- BIOLOGICAL Universal Donor Natural Killer Cells
Study Locations (1)
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-02-14 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What NCT05503134 shows while recruiting
NCT05503134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Universal Donor Natural Killer Cells is the first listed.
NCT05503134 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05503134 about?
NCT05503134 is a clinical study titled "Safety and Efficacy of Expanded, Universal Donor Natural Killer Cells for Relapsed/Refractory AML". This is a phase I/II dose escalation study designed to determine the safety and estimate the efficacy of UD-NK cells combined with FLA chemotherapy in patients age 1-24.99 with relapsed or refractory acute myeloid leukemia. PRIMARY OBJECTIVE: I. To determine the safety and recommended phase II dos...
What is the current status of trial NCT05503134?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2022-02-14. Estimated completion is 2027-02.
What conditions does trial NCT05503134 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT05503134?
The interventions under investigation include: Universal Donor Natural Killer Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT05503134?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05503134 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05503134's enrollment target sits among peer trials
20 246th of 306 higher than 50 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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