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

Sponsor
Guangzhou 8th People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03240328
Collaborator
Sun Yat-sen University (Other)
40
1
1
62.9
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Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
No control.No control.
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 :
Oct 4, 2017
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of treatment-associated adverse events of CAR-T cell therapy [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 [6 Months]

    To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma

  2. HIV viral load rebound time [6 months]

    To assay the HIV viral load rebound period after discontinuing cART

Other Outcome Measures

  1. HIV-specific immunity [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guangzhou 8th People's Hospital Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Guangzhou 8th People's Hospital
  • Sun Yat-sen University

Investigators

  • Principal Investigator: Cai Weiping, Bachelor, Guangzhou 8th People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier:
NCT03240328
Other Study ID Numbers:
  • 20170407V3
First Posted:
Aug 7, 2017
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2021