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 efficacy data as outlined by the FDA guidance for long-term follow-up for GT products.
Study Type
OBSERVATIONAL
Enrollment
400
Safety follow-up for A2 Bio GT products administered in a previous interventional study
Banner Health
Gilbert, Arizona, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone Medical Center
New York, New York, United States
Long-term safety of previous A2 Bio GT treatment
Long-term safety of previous A2 Bio GT treatment as determined by incidence of adverse events (AEs)
Time frame: 15 years post treatment with A2 Bio GT product
Overall survival
The time from dosing of A2 Bio GT product to the date of death from any cause
Time frame: 15 years post treatment with A2 Bio GT product
Long-term durability of clinical effect of previous A2 Bio GT treatment
Long-term durability of clinical effect of previous A2 Bio GT treatment as measured by duration of response (DOR)
Time frame: 15 years post treatment with A2 Bio GT product
Progression Free Survival (PFS)
Time from dosing of A2 Bio GT products to the date of disease progression or death from any cause, whichever occurs earlier
Time frame: 15 years post treatment with A2 Bio GT product
Incidence of RCL detected in blood
RCL will be tested on blood by ddPCR as applicable based on FDA guidance
Time frame: 15 years post treatment with A2 Bio GT product
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