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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05529342

Enrollment

Registered

2022-09-07

Start date

2022-08-29

Completion date

2038-09-29

Last updated

2022-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Long term follow-up, Genetically modified CD4 T cells, Gene Therapy, Lentivirus vector

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.

Interventions

BIOLOGICALGene modified therapy

No investigational cell product will be administered

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026