Trials / Enrolling By Invitation
Enrolling By InvitationNCT06885424
A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products
A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2Bio) Gene Therapy (GT) Products
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (estimated)
- Sponsor
- A2 Biotherapeutics Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Solid Tumor Cancer
- Solid Tumor, Unspecified, Adult
- Colorectal Carcinoma
- Colorectal Carcinoma (CRC)
- Non Small Cell Lung Cancer
- Small Cell Lung Cancer ( SCLC )
- Pancreatic Cancer
- NSCLC
- Mesothelioma
- Ovarian Cancer
- Ovarian Carcinoma
- Head and Neck (HNSCC)
- Head and Neck Cancer
- Renal Cell Carcinoma (Kidney Cancer)
- Triple Negative Breast Cancer (TNBC)
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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 |
Timeline
- Start date
- 2025-08-31
- Primary completion
- 2030-03-31
- Completion
- 2040-03-31
- First posted
- 2025-03-20
- Last updated
- 2025-07-15
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06885424. Inclusion in this directory is not an endorsement.