A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products
NCT ID: NCT06885424
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
400 participants
OBSERVATIONAL
2025-08-31
2040-03-31
Brief Summary
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Detailed Description
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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 efficacy data as outlined by the FDA guidance for long-term follow-up for GT products.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants that received A2 Bio GT products
No additional intervention administered in this long term follow-up study
Safety follow-up for A2 Bio GT products administered in a previous interventional study
Interventions
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No additional intervention administered in this long term follow-up study
Safety follow-up for A2 Bio GT products administered in a previous interventional study
Eligibility Criteria
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Inclusion Criteria
2. Able to provide written informed consent for this long-term follow-up study
3. Able to comply with study requirements
18 Years
ALL
No
Sponsors
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A2 Biotherapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Ng, MD
Role: STUDY_DIRECTOR
A2 Biotherapeutics
Locations
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Mayo Clinic
Rochester, Minnesota, United States
NYU Langone Medical Center
New York, New York, United States
Countries
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Related Links
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A2 Bio Website
Other Identifiers
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A2B101-201
Identifier Type: -
Identifier Source: org_study_id
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