Colorectal Carcinoma, Colorectal Carcinoma (CRC), Head and Neck Cancer, Head and Neck (HNSCC), Mesothelioma, Non Small Cell Lung Cancer, NSCLC, Ovarian Cancer, Ovarian Carcinoma, Pancreatic Cancer, Renal Cell Carcinoma (Kidney Cancer), Small Cell Lung Cancer ( SCLC ), Solid Tumor Cancer, Solid Tumor, Unspecified, Adult, Triple Negative Breast Cancer (TNBC)
Conditions
Keywords
CAR T Cell Therapy, Gene Therapy
Brief 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.
Detailed description
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.
Interventions
OTHERNo additional intervention administered in this long term follow-up study
Safety follow-up for A2 Bio GT products administered in a previous interventional study
Sponsors
A2 Biotherapeutics Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term safety of previous A2 Bio GT treatment | 15 years post treatment with A2 Bio GT product | Long-term safety of previous A2 Bio GT treatment as determined by incidence of adverse events (AEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 15 years post treatment with A2 Bio GT product | The time from dosing of A2 Bio GT product to the date of death from any cause |
| Long-term durability of clinical effect of previous A2 Bio GT treatment | 15 years post treatment with A2 Bio GT product | Long-term durability of clinical effect of previous A2 Bio GT treatment as measured by duration of response (DOR) |
| Progression Free Survival (PFS) | 15 years post treatment with A2 Bio GT product | Time from dosing of A2 Bio GT products to the date of disease progression or death from any cause, whichever occurs earlier |
| Incidence of RCL detected in blood | 15 years post treatment with A2 Bio GT product | RCL will be tested on blood by ddPCR as applicable based on FDA guidance |
Countries
United States
Contacts
STUDY_DIRECTOREric Ng, MD
A2 Biotherapeutics
Outcome results
None listed