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OncoMatch/Clinical Trials/NCT06158828

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

Is NCT06158828 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for aml, childhood.

Phase 1/2RecruitingWashington University School of MedicineNCT06158828Data as of Jun 2026

Treatment: Rabbit Anti thymocyte globulin · Busulfan · Fludarabine · Thiotepa · Melphalan · TCR alpha beta / CD19+ depleted haploidentical hematopoietic progenitor cell graft · memory-like natural killer cells · IL-2 · Plerixafor · Granulocyte Colony-Stimulating Factor · CliniMACSThis trial represents a single institution phase I/II pilot study with the primary objective of establishing the safety and feasibility of generating and infusing ML NK cells after TCRαβ haplo-HCT.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

BusulfanFludarabineThiotepaMelphalan

Other

Rabbit Anti thymocyte globulinTCR alpha beta / CD19+ depleted haploidentical hematopoietic progenitor cell graftmemory-like natural killer cellsIL-2PlerixaforGranulocyte Colony-Stimulating FactorCliniMACS

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: RPN1 RPN1-MECOM

RPN1-MECOM

Required: RUNX1 RUNX1-MECOM

RUNX1-MECOM

Required: NPM1 NPM1-MLF1

NPM1-MLF1

Required: DEK DEK-NUP214

DEK-NUP214

Required: KAT6A KAT6A-CREBBP

KAT6A-CREBBP (if ≥ 90 days at diagnosis)

Required: FUS FUS-ERG

FUS-ERG

Required: KMT2A (MLL) KMT2A-AFF1

KMT2A-AFF1

Required: KMT2A (MLL) KMT2A-AFDN

KMT2A-AFDN

Required: KMT2A (MLL) KMT2A-ABI1

KMT2A-ABI1

Required: KMT2A (MLL) KMT2A-MLLT1

KMT2A-MLLT1

Required: NUP98 rearrangement (any partner gene)

11p15 rearrangement (NUP98 - any partner gene)

Required: ETV6 rearrangement (any partner gene)

12p13.2 rearrangement (ETV6 - any partner gene)

Required: ETV6 deletion (loss of ETV6)

Deletion 12p to include 12p13.2 (loss of ETV6)

Required: EGR1 deletion (loss of EGR1)

Monosomy 5/Del(5q) to include 5q31 (loss of EGR1)

Required: FLT3 ITD with allelic ratio > 0.1%, without bZIP CEBPA or NPM1

FLT3/ITD with allelic ratio > 0.1%, without bZIP CEBPA or NPM1

Demographics

Ages ≤ 40

Prior therapy

Must have received: hematopoietic cell transplant

One prior hematopoietic cell transplant is allowed, provided remission criteria as defined above are met.

Lab requirements

Kidney function

GFR ≥ 60 mL/min/1.73m2 or serum creatinine < 2 x IULN for age/gender

Liver function

Total bilirubin ≤ 3 x IULN for age; AST(SGOT)/ALT(SGPT) ≤ 5 x IULN for age

Cardiac function

LVEF at rest ≥50% or shortening fraction (SF) ≥27% (via echocardiogram or MUGA)

Adequate organ function as defined below: Total bilirubin ≤ 3 x IULN for age; AST(SGOT)/ALT(SGPT) ≤ 5 x IULN for age; GFR ≥ 60 mL/min/1.73m2...serum creatinine < 2 x IULN for age/gender. Adequate cardiac function, defined by LVEF at rest ≥50% or SF ≥27%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Washington University School of Medicine · St Louis, Missouri

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Frequently asked questions

Is NCT06158828 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received hematopoietic cell transplant.

Does this trial require RPN1?

Yes, RPN1 RPN1-MECOM is a required biomarker for enrollment.

Does this trial require RUNX1?

Yes, RUNX1 RUNX1-MECOM is a required biomarker for enrollment.

Does this trial require NPM1?

Yes, NPM1 NPM1-MLF1 is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 40 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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