OncoMatch/Clinical Trials/NCT05503134
Safety and Efficacy of Expanded, Universal Donor Natural Killer Cells for Relapsed/Refractory AML
Is NCT05503134 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Universal Donor Natural Killer Cells for acute myeloid leukemia.
Treatment: Universal Donor Natural Killer Cells — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Prior therapy
Cannot have received: AML directed therapy
Exception: hydroxyurea; intrathecal cytarabine, methotrexate and/or hydrocortisone
AML directed therapies in the 2 weeks prior to beginning treatment on this protocol (except for hydroxyurea). Note: There is no waiting period required for patients having received intrathecal cytarabine, methotrexate and/or hydrocortisone
Cannot have received: immunosuppressive therapy
Patients on immunosuppressive therapy. Patients must be off of all systemic immunosuppressive therapy for at least 2 weeks prior to enrollment with no evidence of recurrent GVHD
Cannot have received: donor lymphocyte infusion or cellular therapy
Patients with a history of donor lymphocyte infusion or cellular therapy within the last 30 days are not eligible for this study
Cannot have received: allogeneic stem cell transplant
Allogeneic SCT < 3 months prior to study enrollment
Cannot have received: adoptive cell therapy
Exception: at least 30 days from infusion and with evidence of recovery of normal hematopoiesis (ANC ≥ 500/μL, platelet count ≥ 50,000/μL)
Patients with a history of adoptive cell therapy are excluded unless at least 30 days from infusion and with evidence of recovery of normal hematopoiesis (ANC ≥ 500/μL, platelet count ≥ 50,000/μL).
Lab requirements
Kidney function
creatinine ≤ 2 mg/dl or creatinine clearance > 60 ml/min/1.73m2
Liver function
total bilirubin ≤ 2 mg/dl (unless gilbert's syndrome), ast and alt ≤ 5 times the upper limit of normal (unless related to leukemic involvement)
Cardiac function
left ventricular ejection fraction ≥ 40% or shortening fraction ≥20%. may be eligible after cardiology clearance if qualitatively normal function or repeat measures are normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Nationwide Children's Hospital · Columbus, Ohio
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