Drugs / AGT103-T
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | HIV infectious disease | 2019-10-18 | “submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for AGT's lead HIV program, AGT103-T” americangene.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04561258 | Oct 2020 → Aug 2022 | HIV infectious disease | American Gene Technologies International Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2022-12-22 | American Gene Technologies International Inc. | Results American Gene Technologies® Phase I HIV Gene Therapy Clinical Trial Data Published in Frontiers Journal Shows Success in Safety & Durability americangene.com ↗
The Phase 1 trial demonstrated that AGT103-T — an autologous T cell product that has been modified with the AGT103 lentiviral vector for HIV resistance — was well-tolerated in humans and that these enhanced T cells persist in the body, ready to respond to HIV. |
| 2022-02-02 | American Gene Technologies International Inc. | Results American Gene Technologies ® HIV Clinical Trial Shows Blood Markers of Efficacy in Two More Patients americangene.com ↗
Laboratory studies confirmed substantial increases in virus-specific T cells consistent with improved immunity against HIV in all participants. |
| 2021-12-21 | American Gene Technologies International Inc. | Results American Gene Technologies ® HIV Clinical Trial Demonstrates Blood Markers of Efficacy americangene.com ↗
All three patients achieved engraftment of the genetically modified cell product, AGT103-T, and avoided rejection of the infused cells. |
| 2021-11-09 | American Gene Technologies International Inc. | Results American Gene Technologies Passes Major Milestone in Potential HIV Cure Clinical Trial with Third Patient Showing No Serious Adverse Effects (SAEs) americangene.com ↗
With no serious adverse effects observed in the third participant, we’re seeing a verifiable trend in the data that gives reasonable confidence that the treatment has low risk of adverse events. |
| 2021-09-23 | American Gene Technologies International Inc. | Results American Gene Technologies HIV Cure Clinical Trial Shows Additional Progress with No Serious Adverse Events (SAEs) americangene.com ↗
Without any observed negative or adverse events, the trial can continue without adjustments or delays. |
| 2021-07-16 | American Gene Technologies International Inc. | Results HIV Cure Program Releases Initial Clinical Trial Data americangene.com ↗ |
| 2020-08-11 | American Gene Technologies International Inc. | Regulatory FDA Approves American Gene Technologies (AGT) To Move Forward With Phase 1 Clinical Trial Of HIV Cure Program americangene.com ↗
American Gene Technologies (AGT) announced today approval by the FDA (Food and Drug Administration) to begin Phase 1, the first human clinical trial for AGT’s lead HIV program. |
| 2020-08-03 | American Gene Technologies International Inc. | Results Molecular Therapy Peer-Reviewed Article by AGT and NIAID Outlines Preclinical Data, Shows Potential for HIV Functional Cure americangene.com ↗
The publication describes the evolution of the AGT103-T manufacturing process as researchers developed the large-scale production of modified HIV-specific, CD4 T cells that resist infection and depletion by HIV. |
| 2019-10-18 | American Gene Technologies International Inc. | Regulatory IND Application Submission To FDA For Phase 1 Trial Of Genetically Modified Autologous Cell Therapy For HIV Announced by American Gene Technologies americangene.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AGT103-T | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04561258 ↗ |
| Modality | Cell therapy | “a gene and cell therapy” NCT04561258 ↗ |