Third-Generation CAR-T-cell Therapy in Individuals With HIV-1 Infection — TCTIWHI  

HIV-1 Clinical Trial

Official title: A Phase I Trial Using Third-Generation CAR-T-cell Therapy in Individuals With HIV-1 Infection

Status Not yet recruiting

Clinical Trial Summary

To evaluate the safety of autologous CAR-T-cell therapy in individuals lived with HIV-1 infection, CAR T cells are infused after ex vivo expansion and transduction with lentiviral vectors encoding a broadly neutralizing HIV-1 scFv antibody.

Clinical Trial Description

This study is a prospective, single-center, single-arm, open-label and phase I clinical trial. Subjects with CD4+T cell counts greater than 350/μl and viral loads of <50 copies/ml over 1 year by antiviral treatment are enrolled. T cells are stimulated with CD3 and CD28, transduced with lentiviral vectors encoding a broadly neutralizing HIV-1 scFv antibody and expanded for approximately 2 weeks. Then, patients are infused with CAR T cells at a dosage of 1×10^5 CAR-T cells/kg body weight. If this dose is well tolerated, dosing will be increased to 5×10^5 CAR T cells/kg body weight. After infusion, adverse events, and HIV-1 latent reservoir size and CAR levels in peripheral blood will be monitored to assess the safety of CAR-T-cell treatment, potential therapeutic efficacy and kinetics of CAR T cells. ;

Related Conditions & MeSH terms

• HIV-1
• Infection

• NCT number: NCT04863066
• Study type: Interventional
• Source: Beijing 302 Hospital
• Contact: Jinfang Zhao, MD
• Phone: 010-93332866
• Email: zhaojinfang13@163.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 1, 2021
• Completion date: October 1, 2022