University of Pennsylvania
This research study is being conducted to evaluate an experimental drug called huCART19-IL18-CD428z cells in patients living with HIV who have been diagnosed with Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Acute Lymphoblastic Leukemia (ALL), and Richter's Transformation (RT).
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 cell…
Inclusion Criteria: 1. Signed informed consent form 2. Male or female age ≥ 18 years. 3. HIV-1 infection diagnosed in accordance with WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines. This requires confirmation of the initial test result using a different qualified method from the initial assessment as follows: 1. Any FDA approved rapid HIV test or HIV enzyme/chemiluminescence immunoassay (E/CIA); AND b. A second confirmatory test based on one of the following methods: i. Antibody test from a different manufacturer or based on different pr…
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.
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