TCR alpha beta / CD19+ depleted haploidentical hematopoietic

The HPC product obtained from a haploidentical donor will undergo ex vivo TCR alpha beta and CD19+ depletion, and will be infused fresh on Day 0. There is no maximum limit for CD34+ dose. A maximum dose of 1 x 10\^5/kg recipient weight of TCRαβ cells should not be exceeded in the final HPC product.

The ML NK cells (dose: max capped at 20 x 10\^6/kg recipient weight, minimum dose allowed is 0.5 x 10\^6/kg recipient weight) will be infused on Day +7.

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.

Live record on ClinicalTrials.gov →

• Patient Inclusion Criteria - Cohort 1:
• High risk acute myeloid leukemia (AML) in either:
• 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
• Patients must further meet one of the below for inclusion into the study:
• De novo AML in CR1 with any of the following high-risk features:

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.