Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05529342
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2022-12-02
First Post:
2022-09-02
Brief Title:
Long-term Follow-up of Study Participant Treated With Lentiviral-Based Genetically Modified Autologous Cell Product AGT103-T
Sponsor:
American Gene Technologies International Inc
Organization:
American Gene Technologies International Inc
Study Overview
Official Title:
A Long-Term Follow-Up Study of Participants Treated With the Lentiviral-Based Genetically Modified Autologous Cell Product AGT103-T
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Long-term follow-up of study subjects who received AGT103-T product in HIV study The AGT103-T is genetically modified cells that resist infection with HIV causing a depletion of HIV in HIV-infected study participants
Detailed Description:
The primary objective of this study is to monitor study participant who receive the genetically modified gag specific CD4 T cells for the long term adverse event evaluate sustained impact on immunity and the persistence of vector modified CD4 T cells
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None