drugset / Trial / NCT05129189

Functional Cure Study of Anti-PD-L1 Antibody ASC22 in Combination With Chidamide in HIV-infected Patients With Antiviral Suppression

NCT05129189

Phase 2 Unknown 15 enrolled Shanghai Public Health Clinical Center
NaSingle-groupOpen-labelTreatment

Summary

In HIV-infected patients, enhanced PD-1 expression of T cells correlates with T cell depletion, as evidenced by reduced virus-specific proliferative capacity and decreased cytokine expression.Targeting PD-L1 drugs to block PD-1/PD-L1 signaling may promote the secretion of antiviral cytokines and achieve HIV clearance.The mechanism of action of ASC22 is to competitively block the binding of PD-1 molecules to PD-L1 through its antigen-binding region with a high affinity for hPD-L1, thereby stimulating an innate or adaptive immune response with sustained T-cell activation.This study was conducted to evaluate whether ASC22 combined with chidamide in HIV-infected patients with antiviral suppression could shrink the viral reservoir.

Timeline

Start
2022-06-29
Primary completion
2023-07-30
Completion
2023-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Envafolimab Monoclonal antibody 1 mg/kg Subcutaneous
Subject Tucidinostat Small molecule 10 mg Oral