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

September 13, 2022 updated by: Linghua LI, Guangzhou 8th People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Cai Weiping, Bachelor
  • Phone Number: 020-83710816
  • Email: gz8hcwp@126.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Guangzhou 8th People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV-1 reservoir
Time Frame: 6 Months
To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma
6 Months
HIV viral load rebound time
Time Frame: 6 months
To assay the HIV viral load rebound period after discontinuing cART
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou 8th People's Hospital

Collaborators

Sun Yat-sen University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2017

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

May 21, 2017

First Submitted That Met QC Criteria

August 2, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20170407V3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV/AIDS

Clinical Trials on CAR-T cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe