Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting 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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06158828). StuddyBuddy aggregates publicly available trial information.