Actively Recruiting
Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML
Led by Washington University School of Medicine · Updated on 2026-05-05
68
Participants Needed
1
Research Sites
289 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
T
The Leukemia and Lymphoma Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of high-risk acute myeloid leukemia (AML) in complete remission with less than 5% marrow blasts or morphological leukemia free state
- For Cohort 1: De novo AML in first complete remission with high-risk features, second or later remission, therapy-related AML in first remission, or AML evolving from myelodysplastic syndrome
- For Cohort 2: Treatment refractory or multiply relapsed AML with less than 25% bone marrow blasts
- Age 40 years or younger
- Performance status greater than 60% (Lansky for under 16 years or Karnofsky for 16 years and older)
- Adequate organ function including liver, kidney, heart, and lung function
- Agreement to use effective contraception for women and men during study and for 24 months post-transplant
- Ability to understand and sign informed consent or have a guardian who can
- Availability of a familial haploidentical donor able to undergo two leukapheresis procedures
- Donor and recipient must match at least 5 of 10 HLA alleles
You will not qualify if you...
- Active graft versus host disease (GvHD) or immunosuppression within 3 months prior to treatment
- Active non-hematologic malignancy
- Receiving other investigational agents at transplant
- Active central nervous system or extramedullary leukemia disease
- History of allergic reaction to study agents
- Inability to discontinue medications interfering with ML NK cell activity
- Significant anti-donor HLA antibodies
- Presence of a major disorder that contraindicates transplant
- Diagnosis of Fanconi anemia or Down syndrome
- Uncontrolled infections or unstable cardiac conditions
- Pregnant or breastfeeding women; negative pregnancy test required for women of childbearing potential
- Donors who are pregnant or breastfeeding or do not meet criteria including age, HLA match, and consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
T
Thomas M Pfeiffer, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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