NCT06885424

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
170mo left

Started Aug 2025

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Aug 2025Mar 2040

First Submitted

Initial submission to the registry

March 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

August 31, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2040

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

4.6 years

First QC Date

March 12, 2025

Last Update Submit

July 10, 2025

Conditions

Solid Tumor CancerSolid Tumor, Unspecified, AdultColorectal CarcinomaColorectal Carcinoma (CRC)Non Small Cell Lung CancerSmall Cell Lung Cancer ( SCLC )Pancreatic CancerNSCLCMesotheliomaOvarian CancerOvarian CarcinomaHead and Neck (HNSCC)Head and Neck CancerRenal Cell Carcinoma (Kidney Cancer)Triple Negative Breast Cancer (TNBC)

Keywords

CAR T Cell TherapyGene Therapy

Outcome Measures

Primary Outcomes (1)

  • Long-term safety of previous A2 Bio GT treatment

    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 Outcomes (4)

  • Overall survival

    15 years post treatment with A2 Bio GT product

  • Long-term durability of clinical effect of previous A2 Bio GT treatment

    15 years post treatment with A2 Bio GT product

  • Progression Free Survival (PFS)

    15 years post treatment with A2 Bio GT product

  • Incidence of RCL detected in blood

    15 years post treatment with A2 Bio GT product

Other Outcomes (2)

  • Progression Free Survival 2 (PFS2)

    15 years post treatment with A2 Bio GT product

  • Persistence of of A2 Bio GT

    5 years post treatment with A2 Bio GT product

Study Arms (1)

Participants that received A2 Bio GT products

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

Interventions

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

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

Participants that received A2 Bio GT products

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants previously treated on a A2 Bio GT study

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and Peripheral Blood Mononuclear Cells (PBMCs) will be analyzed for biomarkers and safety testing if required. No further genetic testing will be performed on these samples.

MeSH Terms

Conditions

Colorectal NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaPancreatic NeoplasmsMesotheliomaOvarian NeoplasmsSquamous Cell Carcinoma of Head and NeckHead and Neck NeoplasmsCarcinoma, Renal CellKidney NeoplasmsTriple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal DisordersCarcinoma, Squamous CellCarcinomaAdenocarcinomaUrologic NeoplasmsKidney DiseasesUrologic DiseasesMale Urogenital DiseasesBreast NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Eric Ng, MD

    A2 Biotherapeutics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 20, 2025

Study Start

August 31, 2025

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2040

Last Updated

July 15, 2025

Record last verified: 2025-07

Locations

US(2)