Addimmune HIV Cure Clinical Trial

Follow along with the Addimmune™ team as we track the clinical progress of AGT103-T, our potentially curative HIV therapeutic!


Clinical Trial Progress


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HIV Cure Countdown

This HIV Cure Countdown outlines the critical milestones accomplished so far. We still have a few more to go, so follow along with us as we pursue a gene therapy cure for HIV.

Seven Milestones Completed


FDA Allows Clinical Trial

August 2020

After promising pre-clinical studies, the phase 1 trial for AGT103-T was 'greenlit' for a Phase 1 human trial.


CBS News Baltimore WJZ: "FDA Clears Maryland Company’s Potential HIV Cure For Human Trials"


ABC 7 News WJLA: "MoCo biotech company receives FDA approval for human trials of HIV Cure program"


Phase 1 Began

October 2020

American Gene™ Phase 1 trial officially opened and started seeking trial participants.


First Product Passes Release Testing

April 2021

After Phase 1 began and the trial participants were enrolled, American Gene manufactured AGT103-T and passed an extensive panel of safety testing.


First Patient Infused

May 2021

The very first trial participant received an infusion of AGT103-T.


HIV Breakthrough at American Gene Technologies Gets Researchers Closer to the Cure


HIV Cure Program Clinical Trial Update - Spring 2021


AGT Announces Progress With HIV Cure Program - ABC 7 Interview with CEO Jeff Galvin


ABC 7 News Interview with Dr. Jose Bordon who Infused HIV Therapy to First Participant In Phase 1


Three Patients with No Serious Adverse Events; DSMB Accelerates Trial

November 2021

After no serious adverse events were recorded from the first 3 patients, the DSMB voted unanimously to continue the program at a faster pace. The 4th and 5th patient were treated in November 2021.


First Five Patients Show Critical Efficacy Markers

February 2022

The AGT103-T gene and cell therapy was tested on participants, giving us a sneak peek at efficacy data that normally occurs in Phase 2. The initial data showed blood markers of efficacy in all five clinical trial participants.

Upcoming Milestones

  • blue-upcoming

    3) First Human Efficacy

    Given that participants in the study are living with HIV and have been given a therapeutic dose of the experimental drug, American Gene may actually see some patients go into durable remission and be able to go off of their ARTs.

  • blue-upcoming

    2) Phase 2 Approved

    A successful Phase 1 will lead to a Phase 2 study, which could be pivotal. Gene and cell therapies frequently get limited license in a Phase 2 study. 

  • blue-upcoming

    1) Phase 2 Completed

    Successful completion of a Phase 2 study may give us the ability to apply for a limited license, sometimes referred to as a BLA. The FDA will consider whether sufficient safety has been shown, and if efficacy is attractive.

  • blue-upcoming

    0) Biologics License Agreement (BLA)

    We’re hopeful that our clinical successes will merit a license. Provided the successful clinical studies, the BLA will allow American Gene Technologies to offer the therapy commercially. 

Have Questions? Get Answers.

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