A Phase I/II Pilot Study of Memory-like NK Cells to Consolidate TCRαβ T Cell Depleted Haploidentical Transplant in High-risk AML
Washington University School of Medicine
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 range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 *…
Interventions
- DrugRabbit Anti thymocyte globulin
rATG is administered intravenously over 6-18 hours for a total of 2 to 3 doses. The daily dose is based on body weight and lymphocyte count.
- DrugBusulfan
Busulfan is administered intravenously either Q6H or Q24H, with a recommended target Busulfan AUC of 70-90 mg\*h/L.
- DrugFludarabine
Fludarabine is administered intravenously at a dose of 40 mg/m\^2/dose once daily for 4 days.
- DrugThiotepa
Thiotepa is administered intravenously at a dose of 5 mg/kg/dose Q12H for 2 doses.
- DrugMelphalan
Melphalan is administered intravenously at a dose of 70 mg/m\^2/dose once daily for 2 days.
- BiologicalTCR alpha beta / CD19+ depleted haploidentical hematopoietic progenitor cell graft
Location
- Washington University School of MedicineSt Louis, Missouri