A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy… (NCT06885424) | Clinical Trial Compass
By InvitationNot Applicable
A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products
United States400 participantsStarted 2025-07-31
Plain-language summary
This protocol is to ensure consistent long-term follow-up for delayed safety events in participants who received A2 Bio gene therapy (GT) products.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Received any amount of A2 Bio GT product on a previous A2 Bio interventional study
. Able to provide written informed consent for this long-term follow-up study
. Able to comply with study requirements
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is only enrolling people by invitation who already received an A2 Bio gene therapy product, can you tell me whether I would even be eligible to participate based on my treatment history?
2This trial is specifically tracking long-term safety after gene therapy — what kinds of delayed side effects or late-onset risks are researchers most concerned about watching for in studies like this, and how might that affect my ongoing monitoring plan?
3What does participation in a long-term follow-up study like this actually involve day-to-day — how often would I need to come in for visits, what tests would be done, and how long would I be followed?
4Since this is a follow-up safety study rather than a treatment trial, does enrolling change anything about the standard care or other treatment options I might pursue for my cancer going forward?
5Given that the goal here is to collect long-term safety data on gene therapy I've already received, what information from this study could actually help inform decisions about my future care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Long-term safety of previous A2 Bio GT treatment
Timeframe: 15 years post treatment with A2 Bio GT product