The Effect of CAR-T Cell Therapy on the Reconstitution of HIV-specific Immune Function
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of treatment-associated adverse events of CAR-T cell therapy
研究概览
简要总结
To study the safety and effectiveness of CAR-T Cell therapy on HIV patients whose plasma HIV has been successfully suppressed after cART, which is expected to enhance the res-constitution of HIV-specific immune function to assist the eradication of HIV reservoir.
详细描述
Despite the advent of combined antiretroviral therapy (cART), the persistence of viral reservoirs remains a major barrier to curing human immunodeficiency virus type 1 (HIV-1) infection. Recently, the shock and kill strategy, by which HIV-1 reservoirs could be eradicated following reactivation of latent HIV-1 by latency-reversing agents (LRAs), has been extensively practiced. It is important to reestablish virus-specific and reliable immune surveillance to eradicate the reactivated virus-harboring cells.the VC-CAR-T cells effectively induced the cytolysis of LRA-reactivated HIV-1-infected CD4 T lymphocytes isolated from infected individuals receiving successful cART. Our previous study demonstrated that the special features of genetically engineered CAR-T cells make them a particularly suitable candidate for therapeutic application in efforts to reach a functional HIV cure. In this clinical trial, we intend to study the safety and effectiveness of CAR-T Cell Therapy on HIV patients whose plasma HIV has been successfully suppressed after cART, by observing the adverse events, HIV-1 reservoir and the immune index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infection confirmed.
- •Receiving cART more than 12 months.
- •HIV viral-load < 50 copies/ml and CD4 cell count more than 350 cells/ul.
- •Without serious liver, heart, liver and kidney diseases.
- •The subjects know about the study and volunteer to attend the research and sign the informed consent.
排除标准
- •With active HBV or HCV infection, or serious opportunistic infections.
- •With serious chronic disease such like diabetes, the mental illness,et al
- •History of suffering from pancreatitis during cART.
- •Pregnant or breast-fed.
- •With poor adherence.
- •Unable to complete follow up.
研究组 & 干预措施
CAR-T therapy
Transfusing CAR-T cells at least 1 million clone every time (once or twice) based on cART after attaining plasma HIV suppression (plasma HIV RNA <50 cp/ml) and CD4+ cell count more than 350 cells/ul over 1 year by cART without active HCV or HBV infection or opportunistic infections. If the candidates reach the criteria of discontinuing cART, they will stop cART and receive close observation. Once the plasma HIV viral load rebound to over 1000 cp/ml, they will restart cART immediately.
干预措施: CAR-T cells (Biological)
结局指标
主要结局
Incidence of treatment-associated adverse events of CAR-T cell therapy
时间窗: 6 Months
To observe the adverse events of VC-CAR-T cell therapy on HIV-infected patients during the clinical trial
次要结局
- HIV viral load rebound time(6 months)
- HIV-1 reservoir(6 Months)
研究者
Linghua LI
Vice Chief physician
Guangzhou 8th People's Hospital