Study to Evaluate the Safety of a Gene and Cell Therapy Product in Participants With HIV That is Well-Controlled on Antiretroviral Therapy

Phase 1 Completed 7 enrolled American Gene Technologies International Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1 study to assess the safety of a gene and cell therapy for autologous donor lymphocyte infusion in HIV+ participants with well-controlled viremia on antiretroviral therapy.

Timeline

Start: 2020-10-12
Primary completion: 2022-08-15
Completion: 2022-11-21

Outcome

Met primary endpoint

release “has recorded data that meets the primary and secondary endpoints of its AGT103-T Phase 1 trial.” americangene.com ↗

Publications

Jain A, Liou ML, Xiao L, Canepa GE. Impact of AGT103-T cell and gene therapy on intact HIV proviral reservoirs. AIDS. 2026 Jul 1;40(7):880-884. doi: 10.1097/QAD.0000000000004459. Epub 2026 Feb 11.
Pauza CD, Huang K, Bordon J. Advances in cell and gene therapy for HIV disease: it is good to be specific. Curr Opin HIV AIDS. 2021 Mar 1;16(2):83-87. doi: 10.1097/COH.0000000000000666.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AGT103-T	Cell therapy	1e+08 cells	Other
Subject	AGT103-T	Cell therapy	1e+09 cells	Other