CD19-Car T Cell Therapy for the Treatment of Older Adults With Acute Lymphoblastic Leukemia in First Remission

PRIMARY OBJECTIVE: I. Assess the safety and tolerability of autologous CD19-CAR T cell therapy by evaluation of toxicities including type, frequency, severity, attribution, time course and duration in older patients with B-cell acute lymphoblastic leukemia (ALL) in first morphological complete remission (CR1). SECONDARY OBJECTIVES: I. Assess the feasibility of manufacturing and infusing CD19-CAR T cells in older adults with B-cell ALL in CR1. II. Evaluate the rate of MRD- remission in patients who had MRD+ disease at the time of infusion. III. Evaluate the overall risk of relapse. IV. Evaluate the risk of central nervous system (CNS) relapse (isolated and combined with bone marrow relapse). V. Estimate the 1-year event-free survival (EFS) rate post CD19-CAR T cell therapy. VI. Estimate 1-year overall survival (OS) post CD19-CAR T cell therapy. VII. Describe development of frailty after CD19-CAR T cell therapy. EXPLORATORY OBJECTIVES: I. Measure expansion and persistence of CD19-CAR T cells in peripheral blood (PB), bone marrow (BM) and cerebrospinal fluid (CSF). II. Assess the duration of B-cell aplasia. III. Describe cytokine levels in PB over the study period. OUTLINE: This is a dose-escalation study of CD19-CAR T cell therapy followed by a dose-expansion study. Patients undergo T cell leukapheresis, receive fludarabine and cyclophosphamide intravenously (IV), and then receive CD19-CAR T cell infusion IV on study.