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

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ClinicalTrials.gov Identifier: NCT03240328
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Linghua LI, Guangzhou 8th People's Hospital

Tracking Information
First Submitted Date  ICMJE May 21, 2017
First Posted Date  ICMJE August 7, 2017
Last Update Posted Date July 1, 2020
Actual Study Start Date  ICMJE October 4, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
Incidence of Treatment-Emergent Adverse Events of CAR-T cell therapy [ Time Frame: 6 Months ]
The adverse events of VC-CAR-T cell therapy on HIV-infected patients during the clinical trial
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • HIV-1 reservoir [ Time Frame: 6 Months ]
    To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma
  • HIV viral load rebound time [ Time Frame: 6 months ]
    To assay the HIV viral load rebound period after discontinuing cART
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
The HIV reservoir [ Time Frame: 6 Months ]
To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma
Current Other Pre-specified Outcome Measures
 (submitted: June 7, 2019)
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
Original Other Pre-specified Outcome Measures
 (submitted: August 2, 2017)
The HIV-specific immunity [ Time Frame: 6 Months ]
The number of HIV-specific CD4,CD8 and VC-CAR-T cells in patients with HIV after receiving CAR-T cell therapy
 
Descriptive Information
Brief Title  ICMJE The Effect of Chimeric Antigen Receptor (CAR)-T Cell Therapy on the Reconstitution of HIV-specific Immune Function
Official Title  ICMJE The Effect of CAR-T Cell Therapy on the Reconstitution of HIV-specific Immune Function
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
No control.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV/AIDS
Intervention  ICMJE Biological: CAR-T cells
HIV-1 specific chimeric antigen receptor cells
Study Arms  ICMJE 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.
Intervention: Biological: CAR-T cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Li Linghua, Doctor 020-83710825 llheliza@126.com
Contact: Cai Weiping, Bachelor 020-83710816 gz8hcwp@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03240328
Other Study ID Numbers  ICMJE 20170407V3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Linghua LI, Guangzhou 8th People's Hospital
Study Sponsor  ICMJE Guangzhou 8th People's Hospital
Collaborators  ICMJE Sun Yat-sen University
Investigators  ICMJE
Principal Investigator: Cai Weiping, Bachelor Guangzhou 8th People's Hospital
PRS Account Guangzhou 8th People's Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP