Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy. The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After the second infusion patients will be subjected to immunomodulatory treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.~Primary outcome:~- Registration of the safety profile such as inflammation, fever, pain, changes in blood pressure, pulse and other adverse events.~Weekly for the first 6 weeks, then at 3, 6, 9, 12, 15, 18, 21 and 24 months.~Secondary outcome:~Tumor response, CAR T cell persistence and immunological profile~Determination of tumor size and the tumor marker CD19.~Determination of the levels of circulating B cells.~Determination of the level of CAR T cells (mRNA and cells) in blood and biopsies.~Determination of activation markers on CAR T cells such as CD107a.~Determination of the presence of immunological markers in blood and biopsies.~At 1 and 3 weeks then at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy.