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NCT Number: NCT06885424

A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) 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.

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Key information

Conditions

Solid Tumor Cancer Adenocarcinoma Adenoma Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Colonic Diseases Colorectal Carcinoma Colorectal Carcinoma (CRC) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck (HNSCC) Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Mesothelioma NSCLC Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Non Small Cell Lung Cancer Ovarian Cancer Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Renal Cell Carcinoma (Kidney Cancer) Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Cancer ( SCLC ) Small Cell Lung Carcinoma Solid Tumor, Unspecified, Adult Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms Triple Negative Breast Cancer (TNBC) Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner Health, Gilbert, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • There are no specific exclusion criteria for this study

Treatment and study plan

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

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

A2 Biotherapeutics Inc.

Industry

Registry information

Official study title

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

Acronym: DESCENT-1

Important dates

Study start
2025
Primary completion
2030
Study completion
2040
First posted
Mar 20, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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