Solid Tumor CancerDESCENT-1NCT06885424
A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products
An observational study of Solid Tumor Cancer and Solid Tumor, Unspecified, Adult, run by A2 Biotherapeutics Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer, Solid Tumor, Unspecified, Adult, Colorectal Carcinoma
- What is being tested?
- No additional intervention administered in this long term follow-up study
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Jul 2025to 31 Mar 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants previously treated on a A2 Bio GT study
Who may be able to join
- 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
Who cannot join
- 1. There are no specific exclusion criteria for this study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Banner Health
Gilbert, Arizona, 85234
NYU Langone Medical Center
New York, New York, 10016
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumor Cancer, Solid Tumor, Unspecified, Adult, Colorectal Carcinoma, Colorectal Carcinoma (CRC), Non Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC )
- Being tested
- No additional intervention administered in this long term follow-up study
- Keywords
- CAR T Cell Therapy, Gene Therapy
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Pancreatic Neoplasms, Mesothelioma, Ovarian Neoplasms, Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Participants that received A2 Bio GT products | Not described Receives: Other: No additional intervention administered in this long term follow-up study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 15 years post treatment with A2 Bio GT product
Secondary outcomes (4)
Overall survival
The time from dosing of A2 Bio GT product to the date of death from any cause
Measured: 15 years post treatment with A2 Bio GT product
Long-term durability of clinical effect of previous A2 Bio GT treatment
Long-term durability of clinical effect of previous A2 Bio GT treatment as measured by duration of response (DOR)
Measured: 15 years post treatment with A2 Bio GT product
Progression Free Survival (PFS)
Time from dosing of A2 Bio GT products to the date of disease progression or death from any cause, whichever occurs earlier
Measured: 15 years post treatment with A2 Bio GT product
Incidence of RCL detected in blood
RCL will be tested on blood by ddPCR as applicable based on FDA guidance
Measured: 15 years post treatment with A2 Bio GT product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start31 Jul 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A2 Biotherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Ng, MD, Study director, A2 Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885424
- Sponsor's protocol ID
- A2B101-201
- Acronym
- DESCENT-1
- Status last verified
- May 2026
- First submitted
- 12 Mar 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2Bio) Gene Therapy (GT) Products
- ClinicalTrials.gov ID
- NCT06885424
- Acronym / sponsor ID
- DESCENT-1 / A2B101-201
- Conditions
- Solid Tumor Cancer, Solid Tumor, Unspecified, Adult, Colorectal Carcinoma, Colorectal Carcinoma (CRC), Non Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC )
- Keywords
- CAR T Cell Therapy, Gene Therapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- A2 Biotherapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2040 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants that received A2 Bio GT products | – | Other: No additional intervention administered in this long term follow-up study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants previously treated on a A2 Bio GT study
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 1. There are no specific exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No additional intervention administered in this long term follow-up studySafety follow-up for A2 Bio GT products administered in a previous interventional study | Other | Participants that received A2 Bio GT products |
Primary outcome
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)
4 secondary outcomes
Overall survival
Time frame: 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
Progression Free Survival (PFS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- A2 Bio WebsiteLink provided by the sponsor.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Ng, MD study director
A2 Biotherapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor Cancer and Solid Tumor, Unspecified, Adult, run by A2 Biotherapeutics Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety of previous A2 Bio GT treatment (time frame: 15 years post treatment with A2 Bio GT product). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.