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Enrolling by Invitation

NCT Number: NCT05529342

Long-term Follow-up of Study Participant Treated With 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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Georgetown University, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Did not receive the investigational product, AGT103-T

Treatment and study plan

Gene modified therapy

Biological

No investigational cell product will be administered

Primary outcomes

  1. Assess the incidence of delayed adverse events (AE) to gene therapy

    Time frame: 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 outcomes

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

American Gene Technologies International Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2038
Study completion
2038
First posted
Sep 7, 2022
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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