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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05529342
• Other study ID #: AGT103-T-LTFU
• Status: Enrolling by invitation
• Start date: August 29, 2022
• Est. completion date: September 29, 2038

Study information

• Verified date: November 2022
• Source: American Gene Technologies International Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7
• Est. completion date: September 29, 2038
• Est. primary completion date: May 23, 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Biological:
• Gene modified therapy
No investigational cell product will be administered

Locations

Country	Name	City	State
United States	Georgetown University	Washington	District of Columbia
United States	Washington Health Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
American Gene Technologies International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The persistence and the immunity impact of the vector-modified T cells	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)	1year to 15 years