A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products (DESCENT-1)

A2 Biotherapeutics

Status

Invitation-only

Conditions

Colorectal Carcinoma

Solid Tumor Cancer

Triple Negative Breast Cancer (TNBC)

Ovarian Carcinoma

Non Small Cell Lung Cancer

Ovarian Cancer

Colorectal Carcinoma (CRC)

Head and Neck (HNSCC)

Small Cell Lung Cancer ( SCLC )

Solid Tumor, Unspecified, Adult

Mesothelioma

Head and Neck Cancer

Renal Cell Carcinoma (Kidney Cancer)

NSCLC

Pancreatic Cancer

Treatments

Other: No additional intervention administered in this long term follow-up study

Study type

Observational

Funder types

Industry

Identifiers

NCT06885424

A2B101-201

Details and patient eligibility

About

This protocol is to ensure consistent long-term follow-up for delayed safety events in participants who received A2 Bio gene therapy (GT) products.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Received any amount of A2 Bio GT product on a previous A2 Bio interventional study
Able to provide written informed consent for this long-term follow-up study
Able to comply with study requirements

Exclusion criteria