This pilot early phase I trial studies the side effects and best dose of laboratory treated T-cells in treating patients with cluster of differentiation (CD)19+ chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back receiving ibrutinib. White blood cells (called T cells) are taken from the patient and modified so that they can identify and possibly kill the cancerous cells. The modification is a genetic change, or gene transfer, to the normal T-cells. These modified cells are called (CART-19) T-cells which are then given back to the patient and this may be a better treatment in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02640209.
PRIMARY OBJECTIVES:
I. Assess safety and feasibility of CART-19 (CD19CAR-CD3zeta-4-1BB-expressing autologous T-lymphocytes) administration in combination with ibrutinib.
SECONDARY OBJECTIVES:
I. Estimate efficacy of CART-19 cells with concurrent ibrutinib treatment.
II. Dose feasibility.
III. Evaluate additional efficacy parameters and other clinical outcomes.
IV. Characterize CART-19 cell levels and function.
TERTIARY OBJECTIVES:
I. Understand modulation of systemic levels of soluble immune and inflammatory factors by CART-19 and other cells.
II. Determine incidence of CD19 escape mutants.
III. Assess T cell phenotype and function and immunogenicity ex vivo at baseline and after CART19 infusion.
IV. Molecular dissection of leukemia-CART19 interplay.
OUTLINE:
Patients receive CD19CAR-CD3zeta-4-1BB-expressing autologous T-lymphocytes intravenously (IV) on days 1-3 (1 to 4 days after completion of cytoreductive chemotherapy).
After completion of study treatment, patients are followed up at days 4, 7, 10, 14, 21, and 28, monthly for 6 months, at 9 and 12 months, and then every 3-6 months for 15 years.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorSaar Gill