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

NCT ID: NCT06885424

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2040-03-31

Brief Summary

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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.

Detailed Description

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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

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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)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants that received A2 Bio GT products

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

Intervention Type OTHER

Safety follow-up for A2 Bio GT products administered in a previous interventional study

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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A2 Biotherapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Ng, MD

Role: STUDY_DIRECTOR

A2 Biotherapeutics

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

NYU Langone Medical Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.a2bio.com

A2 Bio Website

Other Identifiers

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A2B101-201

Identifier Type: -

Identifier Source: org_study_id

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