The Effect of Chimeric Antigen Receptor (CAR)-T Cell Therapy on the Reconstitution of HIV-specific Immune Function

Официальное название

The Effect of CAR-T Cell Therapy on the Reconstitution of HIV-specific Immune Function

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат CAR-T cells
  HIV-1 specific chimeric antigen receptor cells

Первичные конечные точки

• Incidence of treatment-associated adverse events of CAR-T cell therapy [Срок оценки: 6 Months]

Вторичные конечные точки (2)

• HIV-1 reservoir [Срок оценки: 6 Months]
• HIV viral load rebound time [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangzhou 8th People's Hospital — Гуанчжоу

Публикации

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Идентификаторы

NCT: NCT03240328 · 20170407V3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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