Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Acute Myeloid Leukemia

Interventions

  • BIOLOGICAL Universal Donor Natural Killer Cells

Study Locations (1)

Ohio

  • Nationwide Children's Hospital - Columbus

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2022-02-14
Est. Completion 2027-02
Phase Phase 1

Sponsor

Nationwide Children's Hospital

188 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05503134

The ClinicalTrials.gov registry entry for NCT05503134 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (83% lower). The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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

Similar trials for Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Acute Myeloid Leukemia

All registered trials for this condition

Ohio

All trials with a study site in Ohio

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.