CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies
brief summary
Sometimes researchers change the DNA (genetic material in cells) of donated T cells (white blood cells that support the immune system) using a process called "gene transfer." Gene transfer involves drawing blood from the patient, and then separating out the T-cells using a machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject the changed T-cells into the body of the patient. The goal of this clinical research study is to learn if an investigational type of gene transfer can be given reliably and safely in patients with advanced B-cell lymphoma. B cells are a type of white blood cell that fights infection and disease. Lymphoma is a type of cancer that affects the immune system, including B cells. The gene transfer involves drawing blood, separating out T cells (white blood cells that fight infection and disease), changing the T cells' DNA (genetic material) in a specific way, and returning the changed T cells back to the body. Researchers want to learn the highest dose of the changed T cells that can be given safely. Researchers also want to learn how long the changed T cells remain in the participant's body, and if the changed T cells can reliably treat B-cell lymphoma. Finally, researchers want to learn if interleukin-2 (IL-2) can help the changed T cells last longer in the body.
detailed description
Study Plan:
This study has 3 steps: chemotherapy, a stem cell transplant, and gene transfer. If the disease relapses (returns) during the study, you may receive the T-cell infusion without having a stem cell transplant. Your study doctor will decide if you will receive the stem cell transplant or not.
The chemotherapy combination in this study (carmustine \[BiCNU®\], cytarabine \[Cytosar-U®\], etoposide \[Vepesid®\], and melphalan \[Alkeran®\] is given to try to destroy any remaining tumor cells and prepare the body for the stem cell transplant and/or T-cell infusion.
If you receive the T cells without transplant, you may receive additional chemotherapy before the T cell infusion, if your doctor thinks it is needed. Your treating doctor will discuss these chemotherapy drugs with you, and you may sign an additional consent for those chemotherapy drugs as standard of care.
A stem cell transplant is designed to help the body attack the cancer cells that may remain after chemotherapy.
The gene transfer involves drawing blood, separating out T cells, changing the cells' DNA in the laboratory, and returning the genetically changed cells back to the body. T cells are a type of white blood cell that fight infection. The type of gene transfer being used in this study is designed to help your T cells better fight B-cell lymphoma. These genetically changed T cells are designed to fight B-cell lymphoma by targeting CD19 (a chemical "marker" that is found on certain B-cell lymphoma cells).
IL-2 (Proleukin®) is designed to help T cells grow. In this study, researchers want to learn if it can help the genetically changed T cells grow and last longer in the body.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of T cells, with or without IL-2, based on when you joined this study.
The first group of participants will receive the lowest dose of T cells. Each new group will receive a higher dose of T cells than the group before it, if no intolerable side effects were seen. Up to 4 dose combinations of T cells will be tested.
Tests Before Leukapheresis: