This is an open-label, pilot, phase 1 study to determine the safety profile of anti-CD19 CAR-T cell infusion in participants with R/R B-cell NHL. The dose-finding cohorts in this study will evaluate and define the safe dose of anti-CD19 Chimeric antigen receptor T cells (CAR-T) cells. Using a 3+3 design, participants will be enrolled sequentially to each dose level. A dose expansion will then occur at the maximum tolerated dose (MTD) and dose levels that have not exceeded the MTD.~PRIMARY OBJECTIVES~To evaluate the safety of administering chimeric antigen receptor T cells targeting CD-19 to patients with relapsed or refractory CD19+ B-cell nonHodgkin lymphoma (NHL).~To determine the recommended phase 2 dose (RP2D) for this cellular therapy.~SECONDARY OBJECTIVES~To assess the safety and toxicity of cell collection and infusion of CAR-T cells targeting CD19 in patients with relapsed or refractory CD19+ B cell NHL.~To describe the efficacy of chimeric antigen receptor T cells targeting CD-19 in patients with relapsed or refractory CD19+ B cell NHL.~To evaluate the feasibility of CD19 CAR T cell manufacturing for patients with relapsed or refractory CD19+ B cell NHL of local manufacturing and ability to produce adequate quantities of vector positive T-cells.~OUTLINE~Eligible participants will undergo apheresis with collection of autologous peripheral blood mononuclear cells that will be used to generate CAR-T cells. The CAR T cells will be produced using the Miltenyi Prodigy, and an FDA compliant Lentigen Technology, Inc., CD19 targeted lentiviral vector. After successful generation of the anti-CD19 CAR-T cells (drug product (DP)), subjects will undergo lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by 2-5 days of rest. A single infusion of anti-CD19 CAR-T cells at the starting dose of 5 x 105 cells/kg will be given on Day=0. Following treatment with DP, subjects will be followed on this study for 12 months for safety, disease status, and survival. For long term follow-up, participants will be followed for 15 years.~For participants whose dose does not meet the target dose, enrollment into a conforming product low-dose cohort, at minimum dose level - 1 and that has not exceeded the MTD will occur. This conforming product low-dose cohort will be evaluated for toxicity and efficacy of those lower dose levels as part of the primary safety and secondary objectives.~For participants whose CAR-T product does not meet the pre-specified release criteria, enrollment into a non-conforming product cohort, at a minimum dose level - 1 and that has not exceeded the MTD will occur. This non-conforming product cohort will be evaluated for toxicity and efficacy of the non-conforming product cohort as part of the exploratory objectives
This study will assess safety and feasibility of infusing genetically modified autologous T cells transduced to express a chimeric antigen receptor targeting the B cell surface antigen Cluster of Differentiation 19 (CD19)