CAR T cell therapy has shifted the treatment landscape for pediatric and young adult patients with advanced B-cell leukemias. However, the manufacturing process remains in its first generation: difficult, time-consuming, and not automated. The time and significant resources in this process can result in patient safety issues - with patients growing sicker, with harder to control leukemias - in the waiting period. Use of the CliniMACS Prodigy platform can help to surmount these issues. This study will determine the safety and usefulness of using the CliniMACS Prodigy platform to manufacture huCART19 cells.

This is a Phase 1/2b trial for the treatment of patients with either advanced or refractory B cell Acute Lymphoblastic Leukemia or B-lineage lymphoblastic lymphoma who will be treated with huCART19, which has been manufactured using the CliniMACs Prodigy Platform. Possible procedures include medical record review, apheresis, huCART19 infusion, blood draws, physical exams, imaging, and disease assessments through bone marrows and lumbar punctures. Overall, approximately 89 subjects will be enrolled on this clinical trial.

This study involves taking a study drug called SAR443579. The overall goal of this study is to find out if the study drug is safe and effective at treating adults and children with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic syndrome (HR-MDS), or B-cell acute lymphoblastic leukemia (B-ALL). This is a first-in-human research study.