Visit our knowledge base for answers to FAQs about American Gene Technologies' HIV cure program and Phase 1 clinical trial.
HIV Cure
Clinical Trial
Clinical Trial Progress Update
March 27, 2023
American Gene Technologies® has completed our Phase 1 clinical trial and we are currently preparing to submit the final report to the FDA. In the meantime, we are designing the Phase 2 clinical trial protocol and working to identify manufacturers and trial sites. As we review the Phase 1 data with potential collaborators and partners, the response has been consistently enthusiastic to participate in the Phase 2. The analytic treatment interruption has already highlighted impressive viral suppression and immunological data for three out of the six participants who agreed to enroll from the Phase 1, and we are still collecting data on the other three participants.
We expect to discuss the Phase 2 with the FDA this summer, and hope to initiate the trial this year. Pending FDA approval of the Phase 2, data-collection should complete late 2024 or early 2025.
Clinical Trial Progress
American Gene Technologies’ first-in-human Phase 1 study for AGT103-T is currently underway at trial sites in the Washington, D.C. area. Seven patients have received AGT103-T and have experienced no serious adverse events, thereby demonstrating the therapy’s safety. Blood markers in the treated patients have provided a view into how the cell therapy is responding in their bodies. So far, the data has confirmed that the cells are properly engrafting, persisting, and seem to be remaining uninfected while reacting to, and likely fighting HIV the way scientists expected.
The independent Institutional Review Board (IRB) overseeing the clinical trial approved the next step of the clinical trial: analytic treatment interruption (ATI). American Gene Technologies has begun withdrawing participants from their antiretroviral drugs, which will ultimately reveal whether they are cured of HIV, meaning they no longer need daily medication, and can’t develop AIDS or become re-infected with HIV.
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HIV Clinical Trial Timeline
HIV Cure Countdown
American Gene Technologies is making great progress in our ongoing HIV clinical trial. Here is a countdown from when we first started this journey in 2019 to 2022. We highlight key milestones we’ve achieved so far, as well as future developments we are working toward — all in an effort to potentially cure HIV.
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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.
Phase 1 Began
October 2020
American Gene™ Phase 1 trial officially opened and started seeking trial participants.
First Participant Enrolled
October 2020
The first trial participant was enrolled in the Phase 1 trial of AGT103-T.
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.
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.
First Human Efficacy
Upcoming
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.
Phase 2 Approved
Upcoming
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.
Phase 2 Completed
Upcoming
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.
Biologics License Agreement (BLA)
Upcoming
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.
How Does AGT103-T Work?
Watch our CEO break down American Gene Technologies' gene and cell therapy strategy for curing HIV.
As we work toward the next milestone in the HIV Cure Program, learn more about the history of HIV that has been developing over the last 40 years.
