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Pilot Study of Memory-like Natural Killer Cells for Pediatric AML

This study is a pilot trial for children and young adults with high-risk acute myeloid leukemia (AML) who are in remission or a leukemia-free state. It's testing the safety and feasibility of using 'Memory-like Natural Killer (ML NK) cells' after a specific type of stem cell transplant. These ML NK cells are a type of immune cell that may help fight cancer. You would receive a transplant along with medications like Busulfan, Fludarabine, Thiotepa, Melphalan, and Rabbit Anti thymocyte globulin. Researchers will check for safety up to 100 days after transplant and ensure the ML NK cells can be successfully made and given. The study aims to enroll 68 participants, but its current status is unclear.

Study design
This is a single-institution pilot study, which means it's an early-stage trial focused on safety and feasibility. It plans to enroll 68 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured from transplant through Day +100.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06158828

Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML

Recruiting
PHASE1Ages 18+InterventionalTreatment
Washington University School of Medicine
~68 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Rabbit Anti thymocyte globulinBusulfanFludarabineThiotepaMelphalanTCR alpha beta / CD19+ depleted haploidentical hematopoietic progenitor cell graft

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of patients being administered donor-derived ML NK cells following TCR alpha beta depleted haploidentical cell transplant
Measured over From transplant through Day +100
+1 more outcome measured

Conditions

AML, Childhood
Aml
Acute Myeloid Leukemia, Pediatric
Acute Myeloid Leukemia

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NCT06158828

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Washington University School of Medicine

    St Louis, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Thomas M Pfeiffer, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Thomas M Pfeiffer, M.D.
[email protected]
314-273-2070
Email the study team

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Eligibility criteria

Inclusion

MRD ≥ 1% after first induction course
MRD ≥ 0.1% after second induction course
RPN1-MECOM
RUNX1-MECOM
NPM1-MLF1
DEK-NUP214
KAT6A-CREBBP (if ≥ 90 days at diagnosis)
FUS-ERG
KMT2A-AFF1
KMT2A-AFDN
KMT2A-ABI1
KMT2A-MLLT1
11p15 rearrangement (NUP98 - any partner gene)
12p13.2 rearrangement (ETV6 - any partner gene)
Deletion 12p to include 12p13.2 (loss of ETV6)
Monosomy 5/Del(5q) to include 5q31 (loss of EGR1)
Monosomy 7
10p12.3 rearrangement (MLLT10 - any partner gene)
FLT3/ITD with allelic ratio \> 0.1%, without bZIP CEBPA or NPM1
RAM phenotype as evidenced by flow cytometry
Other high-risk features not explicitly stated here, after discussion/approval with protocol PI. 2. De novo AML in ≥ CR2 3. Therapy-related AML in CR1 4. AML evolving from myelodysplastic syndrome (MDS) 3. One prior hematopoietic cell transplant is allowed, provided remission criteria as defined above are met.

Exclusion

A medical condition that poses unacceptable risk, including autoimmune disease, infection, hematologic disorder, malignancy or a pathogenic germline mutation.
Comorbidities that preclude safe administration of granulocyte colony-stimulating factor (G-CSF), placement of a pheresis catheter and/or stem cell collection.
Served as donor in prior haploidentical HCT.
Significant psychosocial or logistical barriers. 2. Donor must be HLA haploidentical (≥ 5/10 and ≤ 9/10 allele match at the -A, -B, -C, DRB1 and DQ loci) by high resolution typing and related to the patient. 3. Donor must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT). 4. Donor must be available and willing to undergo one mobilized and one non-mobilized leukapheresis procedure. 5. Donor may not be pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days prior to initiation of recipient's conditioning regimen, within 7 days of donor stem cell mobilization regimen and prior to second non-mobilized leukapheresis.. 6. Donor must be able to understand and willing to sign an IRB-approved written informed consent document.

What this trial measures

  • Safety of patients being administered donor-derived ML NK cells following TCR alpha beta depleted haploidentical cell transplantFrom transplant through Day +100

    Safety will be determined by events occurring following transplant. Non-relapse mortality, engraftment failure, and development of severe GvHD will be considered events.

  • Feasibility of manufacturing and administering donor-derived ML NK cells following TCR alpha beta depleted haploidentical cell transplantThrough time of ML NK cell infusion (around Day +7)

    Feasibility is defined by product manufacture failure, i.e., the inability to infuse ML NK cells due to product contamination or insufficient cell dose (\<0.5x10\^6 / kg recipient weight).