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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants that received A2 Bio GT products |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No additional intervention administered in this long term follow-up study | Other | Safety follow-up for A2 Bio GT products administered in a previous interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 15 years post treatment with A2 Bio GT product |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from dosing of A2 Bio GT product to the date of death from any cause | 15 years post treatment with A2 Bio GT product |
| Long-term durability of clinical effect of previous A2 Bio GT treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival 2 (PFS2) | Time from start of the next line of treatment after A2 Bio product to the date of disease progression or death from any cause, whichever occurs earlier | 15 years post treatment with A2 Bio GT product |
| Persistence of of A2 Bio GT |
Inclusion Criteria:
Exclusion Criteria:
1. There are no specific exclusion criteria for this study
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Participants previously treated on a A2 Bio GT study
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| Name | Affiliation | Role |
|---|---|---|
| Eric Ng, MD | A2 Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Health | Gilbert | Arizona | 85234 | United States | ||
| Mayo Clinic |
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| Label | URL |
|---|---|
| A2 Bio Website | View source |
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Whole blood and Peripheral Blood Mononuclear Cells (PBMCs) will be analyzed for biomarkers and safety testing if required. No further genetic testing will be performed on these samples.
Long-term durability of clinical effect of previous A2 Bio GT treatment as measured by duration of response (DOR)
| 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 | 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 | 15 years post treatment with A2 Bio GT product |
Amount of A2 Bio GT present in patients treated with A2 Bio GT as assessed by Polymerase Chain Reaction (PCR) (or similar method) on participant blood samples |
| 5 years post treatment with A2 Bio GT product |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D010190 | Pancreatic Neoplasms |
| D008654 | Mesothelioma |
| D010051 | Ovarian Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D006258 | Head and Neck Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D000230 | Adenocarcinoma |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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