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.
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).
Morphological leukemia free state (MLFS) defined by the absence of hematological recovery and < 5% marrow blasts by morphology
MRD ≥ 1% after first induction course
MRD ≥ 0.1% after second induction course
Both Cohorts
Active GvHD. If patient had prior GvHD, patient must be off immunosuppression for at least 3 months prior to starting study treatment.
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.
Currently receiving any other investigational agents at the time of transplant.
Washington University School of Medicine
Lead sponsor
The Leukemia and Lymphoma Society
Collaborator
Rising Tide Foundation
Collaborator
St. Louis Children's Hospital Foundation
Collaborator
Children's Discovery Institute
Collaborator