Phase 1 Study of huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers

This is a phase 1, open-label study to assess the safety, feasibility, and preliminary efficacy of huCART19-IL18-CD428z cells in patients with HIV that have CD19 positive cancers. huCART19-IL18-CD428z cells are genetically modified autologous T cells engineered by co-transduction with two lentiviral vectors: a). huCART19-IL18 targeting the CD19+ B-cells and b). C34-CD4CAR\_CD28 targeting HIV. This investigational product is primarily intended to treat the patient's CD19-positive cancer. However, by co-expressing CD19-targeting and HIV-specific CARs in the same T cell, we aim to use cancer cells to stimulate T-cell growth, which may also help HIV-specific CAR T cells multiply and survive longer in the body. This study will be initiated as a single arm study (Treatment Arm A), which will evaluate a single fixed dose of huCART19-IL18-CD428z cells following lymphodepleting chemotherapy. In participants who have a complete response to the huCART19-IL18-CD428z cells, an optional analytical treatment interruption (ATI) may be performed to evaluate the effectiveness of the CAR T cells to delay or prevent viral rebound in the absence of antiretroviral therapy.