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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 (A2 Bio) Gene Therapy (GT) Products

Enrolling By Invitation
18 years and older
All
Phase N/A

Overview

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

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.

Eligibility

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 exclusion criteria for this study

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Study details
    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)

NCT06885424

A2 Biotherapeutics Inc.

20 July 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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