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

Plain-language summary

This study provides long-term follow-up of participants who were treated with AGT103-T, a genetically modified cell product made from a person's own cells (a gene therapy). It enrolls people who previously received AGT103-T in the AGT-HC168 clinical trial. It is a follow-up study without a phase and enrolls by invitation.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Enrolling by invitation

Sponsor

American Gene Technologies International Inc.

Intervention

Gene modified therapy

Start date

8/29/2022

Estimated completion

9/29/2038

Countries

United States

Related genes

Locations

• Washington D.C., United States
• Washington D.C., United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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