NCT05529342

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
150mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Aug 2022Sep 2038

Study Start

First participant enrolled

August 29, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
15.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2038

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2038

Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

15.7 years

First QC Date

September 2, 2022

Last Update Submit

November 30, 2022

Conditions

HIV

Keywords

Long term follow-upGenetically modified CD4 T cellsGene TherapyLentivirus vector

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The persistence and the immunity impact of the vector-modified T cells

    1year to 15 years

Interventions

Gene modified therapyBIOLOGICAL

No investigational cell product will be administered

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \. Did not receive the investigational product, AGT103-T

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Washington Health Institute

Washington D.C., District of Columbia, 20017, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

August 29, 2022

Primary Completion (Estimated)

May 23, 2038

Study Completion (Estimated)

September 29, 2038

Last Updated

December 2, 2022

Record last verified: 2022-11

Locations

US(2)