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 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:

Trial Details

NCT ID
NCT05503134
Phase
PHASE1 / PHASE2
Sponsor
Nationwide Children's Hospital
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Universal Donor Natural Killer Cells
Locations (sample)
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility Criteria

  • Patients with relapsed or primary refractory AML, including:
  • Patients with relapsed AML (Any patient in first or subsequent relapse are eligible. Patients with relapse after HSCT are eligible)
  • Primary refractory AML defined as failure to achieve a complete response after 2 cycles of induction chemotherapy, including persistent MRD positivity
  • Patients with isolated CNS or extramedullary disease are eligible Note: a response monitoring plan must be developed a priori for subjects with ext…

For full eligibility, visit ClinicalTrials.gov.

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