Skip to content

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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03240328
Enrollment
40
Registered
2017-08-07
Start date
2017-10-04
Completion date
2030-12-31
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Keywords

CAR-T HIV therapy, immunotherapy, function cure

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.

Interventions

BIOLOGICALCAR-T cells

HIV-1 specific chimeric antigen receptor cells

Sponsors

Sun Yat-sen University
CollaboratorOTHER
Guangzhou 8th People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

No control.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of treatment-associated adverse events of CAR-T cell therapy6 MonthsTo observe the adverse events of VC-CAR-T cell therapy on HIV-infected patients during the clinical trial

Secondary

MeasureTime frameDescription
HIV-1 reservoir6 MonthsTo assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma
HIV viral load rebound time6 monthsTo assay the HIV viral load rebound period after discontinuing cART

Other

MeasureTime frameDescription
HIV-specific immunity6 MonthsTo 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

Countries

China

Contacts

Primary ContactLi Linghua, Doctor
llheliza@126.com020-83710825
Backup ContactCai Weiping, Bachelor
gz8hcwp@126.com020-83710816

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026