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

A Long-Term Follow-Up Study of Participants Treated With the Lentiviral-Based Genetically Modified, Autologous Cell Product, AGT103-T

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HIV
• Intervention / Treatment: Biological: Gene modified therapy

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 Type: Observational
• Enrollment (Anticipated): 7

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University
    • Washington, District of Columbia, United States, 20017
      • Washington Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject who received the investigational product AGT103-T in the AGT-HC168 clinical trial

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the incidence of delayed adverse events (AE) to gene therapy	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	1year to 15years post infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The persistence and the immunity impact of the vector-modified T cells	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)	1year to 15 years

Collaborators and Investigators

• Sponsor: American Gene Technologies International Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 29, 2022
• Primary Completion (ANTICIPATED): May 23, 2038
• Study Completion (ANTICIPATED): September 29, 2038

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (ACTUAL): September 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Gene Therapy; Long term follow-up; Genetically modified CD4 T cells; Lentivirus vector
• Other Study ID Numbers: AGT103-T-LTFU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No