The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to see how the T cell with each sort of chimeric receptor lasts, to learn what the side effects are and to see whether this therapy might help people with lymphoma or chronic lymphocytic leukemia (CLL).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00586391.
PRIMARY OBJECTIVES:
I. To evaluate the safety of autologous T-lymphocytes genetically modified to express artificial T-cell receptors (chimeric antigen receptor [CAR]) targeting the cluster of differentiation (CD)19 molecule (CD19CAR) in patients with refractory/relapsed non-Hodgkin’s lymphoma (NHL) or chronic lymphocytic leukemia (B-CLL).
SECONDARY OBJECTIVES:
I. To measure the survival and function of CD19CAR T cells in vivo.
II. To measure the anti-tumor effects of chimeric CD19 receptor transduced autologous T- lymphocytes in patients with non-Hodgkin’s Lymphoma (NHL) or leukemia.
III. To discover if the clinical and laboratory data collected following the additional doses of cells are consistent with a cumulative rise in the percentage of circulating gene modified cells and if the infusions are associated with sequential reductions in patient disease burden.
OUTLINE: This is a dose-escalation study.
Patients receive autologous peripheral blood T-lymphocytes (PBTL) CD19CAR-28 zeta intravenously (IV) over 1-10 minutes. Patients with low or intermediate grade lymphoma/leukemia receive ipilimumab IV over 90 minutes during week 2. Treatment with PBTL CD19CAR-28 zeta may repeat every 4-6 weeks for up to 3 infusions at the discretion of the attending physician.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months, every 6 months for 4 years, and then annually for 10 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorCarlos Almeida Ramos
