Universal Donor Natural Killer Cells for Relapsed/Refractory AML
This study is testing the safety and effectiveness of Universal Donor Natural Killer Cells (UD-NK cells) combined with chemotherapy (Fludarabine and Cytarabine, or FLA) for children and young adults (ages 1-24) with acute myeloid leukemia (AML) that has come back (relapsed) or hasn't responded to previous treatment (refractory). UD-NK cells are a type of immune cell that can fight cancer. You would receive six doses of UD-NK cells over two weeks, given three times a week, and potentially a second cycle if needed. Researchers will be looking closely at any side effects and how well the treatment works. The study aims to find the safest and most effective dose of UD-NK cells.
- Study design
- This is a Phase I/II study enrolling 20 participants. It is designed to test increasing doses of the treatment.
- What's involved
- You would receive Fludarabine and Cytarabine chemotherapy, followed by six doses of UD-NK cells given three times a week for two weeks. This treatment may be repeated for a second cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor you for adverse events and dose-limiting toxicities for up to 56 days after your first UD-NK cell infusion.
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NCT05503134
Safety and Efficacy of Expanded, Universal Donor Natural Killer Cells for Relapsed/Refractory AML
Recruiting
PHASE1Ages 1–24InterventionalTreatmentNationwide Children's HospitalInvestigator-initiated
~20 participants
Updated 2024-11-04 on ClinicalTrials.gov
What's tested:Universal Donor Natural Killer Cells
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events
Measured over Up to 56 days after the first NK cell infusion
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Margaret Lamb, MD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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 extramedullary disease
Patient age 1-24.99 years old
Negative serum test to rule out pregnancy within 2 weeks prior to enrollment in females of childbearing potential
Negative serology for human immunodeficiency virus (HIV)
Both males and females and members of all races and ethnic groups are eligible
Organ function requirements:
Renal 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). Upper limit of normal should be determined by the institutional defined normal laboratory range.
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.
CNS: Patients with seizure disorder may be eligible if seizures well controlled
All prior treatment related non-hematologic toxicities must have resolved to ≤ Grade 2 prior to enrollment unless granted approval by study PI and/or Co-Is.
All patients and/or their legal guardians must be able to understand and willing to sign a written informed consent document
Exclusion
AML directed therapies in the 2 weeks prior to beginning treatment on this protocol (except for hydroxyurea)
Patients on immunosuppressive therapy
Patients with a history of donor lymphocyte infusion or cellular therapy within the last 30 days are not eligible for this study
Allogeneic SCT \< 3 months prior to study enrollment
Any comorbidities that in the opinion of the investigator will preclude receiving study therapy
Performance status: Karnofsky or Lansky Performance Scale (PS) \< 50
Uncontrolled infection, defined as an infection which has not resolved or does not show evidence of significant resolution after initiating appropriate therapy
Uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease
History of autoimmune disease
Active GVHD at the time of enrollment
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).
What this trial measures
- Incidence and severity of adverse eventsUp to 56 days after the first NK cell infusion
- Rate of dose limiting toxicitiesUp to 56 days after the first NK cell infusion