Drug intelligence / Profile preview

AGT103-T

Development stage
Phase 1
Lead developer
American Gene Technologies
Modality
Patient-derived iPSCs → iPSCs → Pluripotent Stem Cells → Stem Cell Therapies → Cell Therapies, Hematopoietic Stem Cells → Adult Stem Cells → Stem Cell Therapies → Cell Therapies, Autologous CAR-T → CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, Mesenchymal Stem Cells → Adult Stem Cells → Stem Cell Therapies → Cell Therapies, Gene Therapies, Tumor-Infiltrating Lymphocytes (TILs) → Native Immune Cells → Adoptive Cell Transfer → Cell Therapies
Administration
Intravenous
01

Overview

AGT103-T is an autologous, genetically engineered cell therapy designed to restore the Gag-specific CD4+ T cell response in people with chronic HIV disease who are receiving antiretroviral therapy. The product consists of a patient’s own CD4+ T cells that are collected, stimulated, and modified ex vivo using a third-generation self-inactivating lentiviral vector (AGT103). This vector expresses a cluster of three engineered microRNAs targeting C-C chemokine receptor type 5 (CCR5, a co-receptor for HIV entry) and two essential HIV genes (Tat and Vif), rendering the modified T cells resistant to both CCR5- and CXCR4-tropic strains of HIV. The goal is to provide durable immune control over HIV by replenishing the pool of functional, virus-resistant Gag-specific CD4+ T cells—mimicking the natural immune control seen in elite controllers or long-term non-progressors. AGT103-T is being developed as a potential functional cure for HIV infection and has completed Phase 1 clinical trials demonstrating safety, persistence of infused cells, enhanced antiviral responses, and no serious adverse events[1][2][3][5][6][7][8].

Other names
AGT103-T cell productAGT-103-T cell productAGT 103-T cell product
02

Targets

CCR5 (C-C chemokine receptor type 5)Human immunodeficiency virus Tat messenger RNAHuman immunodeficiency virus type 1 viral infectivity factor messenger RNA (HIV-1 Vif mRNA)

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