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

NCT ID: NCT05529342

Last Updated: 2022-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-29

Study Completion Date

2038-09-29

Brief Summary

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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

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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.

Conditions

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HIV

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Gene modified therapy

No investigational cell product will be administered

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Gene Technologies International Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Georgetown University

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

Site Status

Washington Health Institute

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

Site Status

Countries

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United States

Other Identifiers

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AGT103-T-LTFU

Identifier Type: -

Identifier Source: org_study_id

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