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

RECRUITINGPHASE1/PHASE2

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

A Phase I/II Pilot Study of Memory-like NK Cells to Consolidate TCRαβ T Cell Depleted Haploidentical Transplant in High-risk AML

NCT06158828•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

This 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. High risk acute myeloid leukemia (AML) in either:
•1. Complete remission (CR) defined by \< 5% marrow blasts by morphology in the context of hematological recovery (ANC ≥ 0.5× 10\^9/L, platelet count ≥ 50 × 10\^9/L).
•2. Morphological leukemia free state (MLFS) defined by the absence of hematological recovery and \< 5% marrow blasts by morphology
•2. Patients must further meet one of the below for inclusion into the study:
•1. De novo AML in CR1 with any of the following high-risk features:
•* MRD ≥ 1% after first induction course
•* MRD ≥ 0.1% after second induction course
•* RPN1-MECOM
•* RUNX1-MECOM
•* NPM1-MLF1
+39 more criteria

Exclusion Criteria

•1. Active GvHD. If patient had prior GvHD, patient must be off immunosuppression for at least 3 months prior to starting study treatment.
•2. Active non-hematologic malignancy. History of other malignancy is acceptable as long as therapy has been completed and there is no current evidence of disease.
•3. Currently receiving any other investigational agents at the time of transplant.
•4. Active CNS or extramedullary disease. History of CNS or extramedullary disease currently in remission is acceptable.
•5. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
•6. Inability to discontinue medications that are likely to interfere with ML NK cell activity, i.e., glucocorticoids and other immunosuppressants.
•7. Presence of significant anti-donor HLA antibodies per institutional standards. Anti-donor HLA - Antibody Testing is defined as a positive crossmatch test of any titer (by complement dependent cytotoxicity or flow cytometric testing) or the mean fluorescence intensity (MFI) of any anti-donor HLA antibody by solid phase immunoassay \> 3000.
•8. Presence of a second major disorder deemed a contraindication for HCT.
•9. Patients with Fanconi Anemia or Down Syndrome.
•10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (bacterial, viral with clinical instability, or fungal), symptomatic congestive heart failure, or unstable cardiac arrhythmia.
+12 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

May 15, 2024

Primary Completion Date

September 15, 2028

Completion Date

May 31, 2030

Last Updated

February 13, 2026

Enrollment

ESTIMATED participants

Conditions

AML, ChildhoodAmlAcute Myeloid Leukemia, PediatricAcute Myeloid Leukemia

Interventions

Rabbit Anti thymocyte globulin

DRUG

Busulfan

DRUG

Fludarabine

DRUG

Thiotepa

DRUG

Melphalan

DRUG

TCR alpha beta / CD19+ depleted haploidentical hematopoietic progenitor cell graft

BIOLOGICAL

memory-like natural killer cells

BIOLOGICAL

IL-2

BIOLOGICAL

Plerixafor

DRUG

Granulocyte Colony-Stimulating Factor

BIOLOGICAL

CliniMACS

DEVICE

Contacts

Thomas M Pfeiffer, M.D.

CONTACT

314-273-2070 pthomas@wustl.edu

Jeffrey Bednarski, M.D., Ph.D.

CONTACT

314-286-2825 bednarski_j@wustl.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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