Long-term Follow-up of Study Participant Treated With Lentiviral-Based Genetically Modified Autologous Cell Product ,AGT103-T
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gene modified therapy.
- Who it may be relevant to
- Registry conditions: HIV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Long-Term Follow-Up Study of Participants Treated With the Lentiviral-Based Genetically Modified, Autologous Cell Product, AGT103-T
Overview
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
- Biological Gene modified therapy
No investigational cell product will be administered
Primary outcome measures
- Assess the incidence of delayed adverse events (AE) to gene therapy [Time frame: 1year to 15years post infusion]
Secondary outcome measures (1)
- The persistence and the immunity impact of the vector-modified T cells [Time frame: 1year to 15 years]
Eligibility criteria
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
1\. Did not receive the investigational product, AGT103-T
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- Georgetown University — Washington D.C.
- Washington Health Institute — Washington D.C.
Identifiers
NCT: NCT05529342 · AGT103-T-LTFU