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

May 18, 2026 updated by: A2 Biotherapeutics Inc.

A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2Bio) Gene Therapy (GT) Products

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner Health
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants previously treated on a A2 Bio GT study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants that received A2 Bio GT products
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term safety of previous A2 Bio GT treatment
Time Frame: 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)
15 years post treatment with A2 Bio GT product

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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
15 years post treatment with A2 Bio GT product
Long-term durability of clinical effect of previous A2 Bio GT treatment
Time Frame: 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)
15 years post treatment with A2 Bio GT product
Progression Free Survival (PFS)
Time Frame: 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
15 years post treatment with A2 Bio GT product
Incidence of RCL detected in blood
Time Frame: 15 years post treatment with A2 Bio GT product
RCL will be tested on blood by ddPCR as applicable based on FDA guidance
15 years post treatment with A2 Bio GT product

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival 2 (PFS2)
Time Frame: 15 years post treatment with A2 Bio GT product
Time from start of the next line of treatment after A2 Bio product to the date of disease progression or death from any cause, whichever occurs earlier
15 years post treatment with A2 Bio GT product
Persistence of of A2 Bio GT
Time Frame: 5 years post treatment with A2 Bio GT product
Amount of A2 Bio GT present in patients treated with A2 Bio GT as assessed by Polymerase Chain Reaction (PCR) (or similar method) on participant blood samples
5 years post treatment with A2 Bio GT product

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A2 Biotherapeutics Inc.

Investigators

  • Study Director: Eric Ng, MD, A2 Biotherapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2025

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2040

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2B101-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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