Washington University School of Medicine
This single arm pilot phase I study with safety run-in is designed to estimate the safety and efficacy of a familial mismatched or haploidentical hematopoietic stem cell transplantation (haplo-HSCT) using a novel graft modification technique (selective αβ-TCR and CD19 depletion).
Recipient Inclusion Criteria: * Must meet at least one of the following disease criteria: * B cell ALL in first remission and any of the following: * Persistent flow-based MRD at end-of-consolidation: * ≥ 1% for NCI SR ALL * ≥ 0.01% for NCI HR ALL * TCF3-HLF t(17;19) * KMT2A rearranged infant ALL, \< 6 months of age and presenting WBC of \> 300,000 or poor steroid response (peripheral blasts \>= 1000 /uL on day 8 of therapy * Other high-risk features not explicitly stated here, after discussion/approval with protocol PI. * B cell ALL in second remission and…
Once pheresed, the product will be washed to remove platelets and the cell concentration will be adjusted per laboratory and ClinicMACS technology recommendations. It is then labeled using the CliniMACS αβ-TCR Biotin Kit and CD19+ immunomagnetic microbeads. After labeling, the cells are washed to remove unbound microbeads. The partially processed product is loaded on the CliniMACS device where labeled cells are depleted and the negative fraction is eluted off the device. The negative fraction is centrifuged and volume reconstituted to obtain the final product
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