Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma
This study tests a new type of cancer treatment called CAR-T therapy, which uses a person's own immune cells to fight lymphoma (a type of blood cancer). The treatment is being studied in patients with HIV who have an aggressive form of lymphoma that has either returned or did not respond to previous treatments.
Key Objective: The trial is testing whether CAR-T therapy can effectively shrink or eliminate aggressive B-cell lymphoma in people living with HIV.
Who to Consider: Patients with HIV who have relapsed or refractory diffuse large B-cell lymphoma that has not responded to standard treatments should consider enrolling.
Trial Parameters
Brief Summary
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.
Eligibility Criteria
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 mediastinal B-cell lymphoma * Follicular lymphoma, grade 3B * Participant must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have R/R disease after at least 2 lines of therapy * At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent * Evaluable disease as either: * Positron