Clinical Trials Engine to Develop an HIV Cure study to test engineered T cells

临床试验引擎开发 HIV 治愈研究来测试工程 T 细胞

• 批准号: 9891738
• 负责人: CHRISTINA M COUGHLIN
• 金额: $ 23.08万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-15 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9891738
• 关键词: Address; Adoptive Transfer; Autologous; B-Cell Neoplasm; Basic Science; Biological Assay; CAR T cell therapy; CD19 gene; Cell Therapy; Cell physiology; Cellular immunotherapy; Childhood Acute Lymphocytic Leukemia; Chronic Lymphocytic Leukemia; Clinical Trials; Clinical Trials Design; Correlative Study; Custom; Data; Disease; Disease remission; Employee; Engraftment; Enrollment; FDA approved; Goals; HIV; HIV Infections; HIV therapy; HIV-1; Healthcare; Hematologic Neoplasms; Highly Active Antiretroviral Therapy; Incentives; Individual; Industry; Infection; Infrastructure; Interruption; Intervention; Knowledge; Letters; Logistics; Malignant Neoplasms; Methods; Modality; Oncology; Outcome; Patients; Pennsylvania; Phase I Clinical Trials; Positioning Attribute; Process; Protocols documentation; Refractory; Regimen; Relapse; Resistance; Rewards; Sampling; Specificity; Structure; T cell therapy; T-Lymphocyte; Technology; Testing; Therapeutic; Time; United States National Institutes of Health; Universities; Work; adverse outcome; cell bank; chimeric antigen receptor; chimeric antigen receptor T cells; clinical center; clinical predictors; cost; design; engineered T cells; experience; gene therapy; improved; improved outcome; insight; integration site; manufacturing facility; manufacturing process; member; novel; novel therapeutics; prevent; process optimization; programs; vector; viral rebound

Project 4 - Abstract The principle that adoptively transferred T lymphocytes have therapeutic promise for HIV infection is well established. Our long range goals are to engineer T cells so that they can control HIV-1 replication in the absence of HAART. Our companies’ scientific founders have pioneered the use of cell and gene therapy to treat HIV-1, and we will use this expertise to better study the relationship between T cells that have been rendered resistant to HIV-1 infection and specific for HIV to control of HIV-1 replication in the absence of ART. Our project serves as a main integration site for this U19 consortium as the most promising approaches generated by Projects 1-3 will be incorporated into Phase I clinical trial that we design, execute and analysis. Additionally, we will develop a commercial T cell manufacturing platform that will give HIV infected individuals access to Chimeric Antigen Receptor (CAR) therapy. The specific aims of this Project are: 1) Define the optimal method to expand T cells for HIV cure studies: Using Tmunity’s T cell expansion expertise and proprietary technology, we will systematically address the best media, artificial APC, and manufacturing platform to develop an optimized protocol to expand highly functional T cells with superior engraftment potential to be used as part of HIV cure regimens. 2) Design and implement a Phase I clinical trial to test the ability of engineered T cells to prevent viral rebound during an analytical treatment interruption: With input from the members of this U19, scientific advisory board (SAB) and NIH program officers, we will plan and execute a Phase I clinical trial that uses this new manufacturing protocol established in Aim 1. 3) Perform correlative studies on samples collected in Aim 2 to develop testable hypotheses that could improve adoptive T cell therapy for HIV infection: Using banked cells collected from informative time points, we will perform validated assays that examine T cell function and persistence and the ability of the chosen intervention to control HIV replication in the absence of ART.

项目4 -摘要