PHASE I SAFETY/FEASIBILITY: GENETICALLY MODIFIED AUTOLOGOUS T CELLS IN LYMPHOMA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Relapsed B cell lymphomas are incurable with conventional therapies except stem cell transplantation, a toxic treatment modality which salvages only 20-50% of patients with recurrent disease. Innovative new treatment approaches are therefore clearly necessary. This phase I study will evaluate the feasibility, safety, toxicity, and efficacy of using gene therapy to treat patients with relapsed or refractory mantle cell or indolent non-Hodgkin's lymphomas. This clinical trial uses genetically modified immune cells to try to improve the body's immune system to fight lymphoma. Immune cells will be taken from the patient's body through leukapheresis, and then genetically modified and expanded to large numbers in a laboratory before being reinfused to the patient in three doses. Twelve people will take part in the study. The first three people who take part received immune cell infusions alone, and the remainder will receive the same treatment, plus the drug interleukin 2 (IL-2) to stimulate the immune cells to grow. In some patients, the second or third dose of cells may be labeled with Indium-111 for assessment of in vivo trafficking The study will examine the safety and toxicity of this approach, how a patient's lymphoma responds to the genetically modified immune cells, how long these cells remain in the body, where the cells travel in the body, and whether the body develops an immune response to these cells.