A2 Biotherapeutics Inc.
This protocol is to ensure consistent long-term follow-up for delayed safety events in participants who received A2 Bio gene therapy (GT) products.
This is a long-term follow-up study designed to evaluate delayed safety events and long-term efficacy of A2 Bio GT products for participants who received any amount of A2 Bio GT products in a previous interventional study. No further interventional treatment is administered in this study. Participants will enroll in this long-term follow-up study upon completion of 2 years of follow-up in the assigned interventional study in which they received treatment. Participants will be followed for up to 15 years after administration of A2 Bio GT product. This study will collect long-term safety and ef…
Inclusion Criteria: 1. Received any amount of A2 Bio GT product on a previous A2 Bio interventional study 2. Able to provide written informed consent for this long-term follow-up study 3. Able to comply with study requirements Exclusion Criteria: 1\. There are no specific exclusion criteria for this study
Safety follow-up for A2 Bio GT products administered in a previous interventional study