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NCT06158828
Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML
Conditions: AML, Childhood, Aml, Acute Myeloid Leukemia, Pediatric, Acute Myeloid Leukemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 68
Sponsor: Washington University School of Medicine
Location: Washington University School of Medicine St Louis Missouri
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 Criteria
Patient Inclusion Criteria - Cohort 1:
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
* 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.
Patient Inclusion Criteria - Cohort 2:
1. High risk acute myeloid leukemia (AML) defined by either of the following:
1. Treatment refractory disease: AML that is not in complete remission despite prior standard or salvage therapies.
2. Multiply relapsed disease: AML that has relapsed after 2 or more hematopoietic cell transplantations.
2. BM disease burden criteria:
1. Bone marrow blasts must be \
Source: ClinicalTrials.gov (NCT06158828). StuddyBuddy aggregates publicly available trial information.