This phase I/II trial studies the side effects and best dose of multi-virus-specific donor T cells to see how well it works in treating patients with B cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, or non-Hodgkin lymphoma who have undergone donor stem cell transplant. Biological therapies may stimulate the immune system in different ways and stop cancer cells from growing. By joining an antibody to the donor T cells that recognize the viruses, it may be able to make the cell that can last a long time in the body, provide protection from viruses, and recognize and kill leukemia.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00840853.
PRIMARY OBJECTIVES:
I. To evaluate the safety and persistence of escalating doses of allogeneic cytomegalovirus (CMV), Epstein-Barr virus (EBV) and adenovirus (tri-virus) specific cytotoxic T-lymphocytes (CTL) genetically modified to express artificial T-cell receptors (CAR) targeting the cluster of differentiation (CD)19 molecule (CD19CAR), given for prophylaxis, persistence or relapse of high risk B-cell malignancies post hemopoietic stem cell transplant (HSCT).
SECONDARY OBJECTIVES:
I. To evaluate the effects of gene modified CTL on measurable disease.
II. To evaluate the impact of the gene modified CTL on virus-specific T-lymphocyte immune reconstitution.
III. To evaluate the impact of the gene modified CTL on normal CD19+ B-cell immune reconstitution post-HSCT.
OUTLINE: This is a dose-escalation study.
Beginning 30 days after HSCT, patients receive CD19CAR selected adenovirus/cytomegalovirus/Epstein-Barr virus-specific allogeneic cytotoxic T lymphocytes intravenously (IV) over 20 minutes. Patients achieving partial response or with stable disease may receive up to 6 further doses.
After completion of study treatment, patients are followed up every 3 months for 1 year, 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