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

NCT ID: NCT03240328

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-04
• Study Completion Date: 2030-12-31

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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CAR-T cells

Intervention Type: BIOLOGICAL

HIV-1 specific chimeric antigen receptor cells

Interventions

CAR-T cells

HIV-1 specific chimeric antigen receptor cells

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Guangzhou 8th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Linghua LI

Vice Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cai Weiping, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Guangzhou 8th People's Hospital

Locations

Guangzhou 8th People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Linghua, Doctor

Role: CONTACT

llheliza@126.com

020-83710825

Cai Weiping, Bachelor

Role: CONTACT

gz8hcwp@126.com

020-83710816

Facility Contacts

Linghua LI, doctor

Role: primary

llheliza@126.com

020-83710825

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Other Identifiers

20170407V3

Identifier Type: -

Identifier Source: org_study_id