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Recruiting Phase 1

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

NCT03240328 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2017-10-04
Last updated
2022-09-14

Condition(s) studied

HIV/AIDS

Investigational drug(s) / intervention(s)

CAR-T cells

CAR-T cells: HIV-1 specific chimeric antigen receptor cells

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Guangzhou 8th People's Hospital Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03240328 on ClinicalTrials.gov ↗ ← All trials in China