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

ConditionHIV/AIDS
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorGuangzhou 8th People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HIV infection confirmed.

Receiving cART more than 12 months.

HIV viral-load < 50 copies/ml and CD4 cell count more than 350 cells/ul.

Without serious liver, heart, liver and kidney diseases.

Disqualifiers

With active HBV or HCV infection, or serious opportunistic infections.

With serious chronic disease such like diabetes, the mental illness,et al

History of suffering from pancreatitis during cART.

Pregnant or breast-fed.

Trial design

Design model

Single group

Treatments tested in this trial

  • CAR-T cells

    Biological/Vaccine

    HIV-1 specific chimeric antigen receptor cells

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: CAR-T therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of treatment-associated adverse events of CAR-T cell therapy

To observe the adverse events of VC-CAR-T cell therapy on HIV-infected patients during the clinical trial

Time frame
6 Months

Secondary outcomes

1

HIV-1 reservoir

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

Time frame
6 Months
2

HIV viral load rebound time

To assay the HIV viral load rebound period after discontinuing cART

Time frame
6 months

Other outcomes

1

HIV-specific immunity

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

Time frame
6 Months

Sponsors and contacts

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Guangzhou 8th People's Hospital

Lead sponsor

Sun Yat-sen University

Collaborator