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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03240328
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Linghua LI, Guangzhou 8th People's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Biological: CAR-T cells Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The control arm includes HIV-infected patients without receiving celluar therapy whose HIV has been successfully suppressed after cART.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of CAR-T Cell Therapy on the Reconstitution of HIV-specific Immune Function
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.
Biological: CAR-T cells
HIV-1 specific chimeric antigen receptor cells

No Intervention: Without CAR-T therapy
Not receiving CAR-T cells transfusion but continuing 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.



Primary Outcome Measures :
  1. Incidence of treatment-associated adverse events of CAR-T cell therapy [ Time Frame: 6 Months ]
    To observe the adverse events of VC-CAR-T cell therapy on HIV-infected patients during the clinical trial


Secondary Outcome Measures :
  1. HIV-1 reservoir [ Time Frame: 6 Months ]
    To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma

  2. HIV viral load rebound time [ Time Frame: 6 months ]
    To assay the HIV viral load rebound period after discontinuing cART


Other Outcome Measures:
  1. HIV-specific immunity [ Time Frame: 6 Months ]
    To assay the remaining concentration of VC-CAR-T cells in patients, the number of HIV-specific CD4,CD8 and their activity after receiving CAR-T cell therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV infection confirmed.
  2. Receiving cART more than 12 months.
  3. HIV viral-load < 50 copies/ml and CD4 cell count more than 350 cells/ul.
  4. Without serious liver, heart, liver and kidney diseases.
  5. The subjects know about the study and volunteer to attend the research and sign the informed consent.

Exclusion Criteria:

  1. With active HBV or HCV infection, or serious opportunistic infections.
  2. With serious chronic disease such like diabetes, the mental illness,et al
  3. History of suffering from pancreatitis during cART.
  4. Pregnant or breast-fed.
  5. With poor adherence.
  6. Unable to complete follow up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240328


Contacts
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Contact: Li Linghua, Doctor 020-83710825 llheliza@126.com
Contact: Cai Weiping, Bachelor 020-83710816 gz8hcwp@126.com

Locations
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China, Guangdong
Guangzhou 8th People's Hospital Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Linghua LI, doctor    020-83710825    llheliza@126.com   
Sponsors and Collaborators
Guangzhou 8th People's Hospital
Sun Yat-sen University
Investigators
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Principal Investigator: Cai Weiping, Bachelor Guangzhou 8th People's Hospital

Publications of Results:
Other Publications:

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Responsible Party: Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier: NCT03240328    
Other Study ID Numbers: 20170407V3
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linghua LI, Guangzhou 8th People's Hospital:
CAR-T HIV therapy
immunotherapy
function cure