OncoMatch/Clinical Trials/NCT05503134
Safety and Efficacy of Expanded, Universal Donor Natural Killer Cells for Relapsed/Refractory AML
Is NCT05503134 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05503134 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior AML directed therapy, immunosuppressive therapy, donor lymphocyte infusion or cellular therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 24 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages