AIDS Malignancy Consortium
This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. Axicabtagene ciloleucel consists of genetically modified T cells, modified to recognize CD-19, a protein on the surface of cancer cells. These CD-19-specific T cells may help the body's immune system identify and kill CD-19-positive B-cell non-Hodgkin lymphoma cells.
PRIMARY OBJECTIVE: I. To demonstrate safety and feasibility of axicabtagene ciloleucel for relapsed/refractory (R/R) human immunodeficiency virus (HIV)-associated aggressive B-cell non-Hodgkin lymphoma (B-NHL) in participants with well-controlled HIV. SECONDARY OBJECTIVES: I. To estimate efficacy of axicabtagene ciloleucel in HIV-associated B-NHL as measured by complete response rate, event-free survival, and duration of response. II. To assess the relationship between T-cell subset profile and clinical response in R/R HIV-associated B-NHL treated with axicabtagene ciloleucel. EXPLORATORY…
Inclusion Criteria: * Participant with age \>= 18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of axicabtagene ciloleucel in participants \< 18 years of age, children are excluded from this study * Participant is able to understand and willing to sign a written informed consent document before any study procedures * Participant must have R/R aggressive B-cell NHL of the following histologies: * Diffuse large B-cell lymphoma (DLBCL, including transformed from indolent histology) * High-grade B-cell lymphoma * Primary mediastina…
Given IV
Given IV
Given IV