Phase 1 Study of Axicabtagene Ciloleucel CAR-T Therapy for Adults With Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating axicabtagene ciloleucel, a CAR-T cell therapy, for patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has returned or not responded to treatment. This phase I trial aims to assess the safety, feasibility, and effectiveness of this therapy in participants with well-controlled HIV. The study also explores the relationship between immune responses, T-cell profiles, and clinical outcomes. Participants receive conditioning chemotherapy with fludarabine and cyclophosphamide intravenously on days -5, -4, and -3, followed by a single intravenous infusion of axicabtagene ciloleucel on day 0. After treatment, participants are monitored weekly for the first month, monthly through six months, and then at 9, 12, 15, 18, and 24 months to track their health and response to therapy. Throughout the study, participants undergo assessments including blood tests to measure CD4 and CD8 T-cell counts and evaluations of lymphoma response using imaging and clinical criteria. Safety and feasibility of the CAR-T therapy are primary outcomes measured over two years. Researchers also examine event-free survival, duration of response, and the burden of HIV integration in the CAR-T product. Participants are followed for up to two years after treatment to monitor these outcomes and any side effects.

Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma