Long-term Follow-up of Study Participant Treated With Lentiviral-Based Genetically Modified Autologous Cell Product ,AGT103-T

• Conditions: HIV

• Registration Number: NCT05529342
• Lead Sponsor: American Gene Technologies International Inc.

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 Timeline

• Study Start: 2022-08-29
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-02
• Primary Completion: 2038-05-23
• Study Completion: 2038-09-29

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Received the investigational product, AGT103-T, in the AGT-sponsored AGT-HC168 clinical trial
2. Provided written informed consent, signed and dated by the study participant in the long-term follow-up study

Exclusion Criteria

1. Did not receive the investigational product, AGT103-T

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the incidence of delayed adverse events (AE) to gene therapy	1year to 15years post infusion	The presence of malignancies, incidence or exacerbation of pre-existing neurologic disorder, new incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, the new incidence of a hematologic disorder post infusion with AGT103T

Secondary Outcome Measures

Name	Time	Method
The persistence and the immunity impact of the vector-modified T cells	1year to 15 years	Evaluate sustained impact on immunity measured by CD4 T cell responses to Gag peptides Measure proportion of participants with absence of replication competent lentivirus (RCL) Measure persistence of vector-modified cells (transgene copies per CD4 T cell)

Trial Locations

Locations (2)

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Washington Health Institute; 🇺🇸 Washington, District of Columbia, United States