Gene Therapy Follow-Up for Cancer
(DESCENT-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to monitor the long-term safety of a gene therapy treatment from A2 Biotherapeutics. It targets individuals who have already received this specific gene therapy in a previous study. The focus is on identifying any delayed safety issues that might arise over time. Participants must understand and agree to the study requirements and provide consent to join this follow-up. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, offering participants the opportunity to contribute to understanding its benefits for more patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this protocol is safe for long-term follow-up?
Research has shown that A2 Bio's gene therapy products were safe in earlier studies. Initial results from the ongoing EVEREST-2 study found that patients generally tolerated the treatment well. While some side effects occurred, they were mostly mild to moderate. This long-term follow-up study aims to monitor any delayed safety issues, ensuring a thorough understanding of the treatment's safety over time. These findings suggest that, while some risks exist, the treatment has been reasonably safe for participants so far.12345
Why are researchers excited about this trial?
Unlike standard treatments that often involve chemotherapy or targeted drugs, A2 Bio's gene therapy is unique because it uses a cutting-edge approach to modify genes directly within cells. This treatment works by precisely altering genetic material to enhance the body's natural ability to fight diseases, offering a potentially more targeted and long-lasting effect. Researchers are excited about this approach because it could lead to fewer side effects and improved outcomes compared to conventional treatments, which generally focus on killing or inhibiting cancer cells indirectly. The hope is that this therapy can provide a more personalized and effective option for patients.
What evidence suggests that this protocol is effective for long-term follow-up of delayed safety events?
Research has shown that A2 Bio gene therapy products, which participants in this trial will receive, hold promise for treating certain conditions. Early studies reported safety and effectiveness, including a complete response (the cancer signs disappeared) in a patient with non-small cell lung cancer (NSCLC). This suggests the therapy could be very effective in some cases. The treatment uses specially modified cells to find and destroy harmful cells in the body. While initial results are encouraging, ongoing studies are needed to gather more information about long-term safety and effectiveness.12346
Who Is on the Research Team?
Eric Ng, MD
Principal Investigator
A2 Biotherapeutics
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Long-term Follow-up
Participants are monitored for delayed safety events and long-term efficacy of A2 Bio GT products
Data Collection
Collection of long-term safety and efficacy data as outlined by FDA guidance for GT products
What Are the Treatments Tested in This Trial?
Interventions
- A2 Biotherapeutics (A2 Bio) Gene Therapy
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
A2 Biotherapeutics Inc.
Lead Sponsor
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06885424?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22A2%20Biotherapeutics%20Inc.%22))&rank=1A Long-Term Follow-Up Study of Participants Treated With ...
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 ...
A2 Bio Announces First Patient Dosed in Phase 1/2 ...
A2 Biotherapeutics Presents Initial Safety and Efficacy Data from Ongoing Phase 1/2 EVEREST-2 Study, Including First Report of a Complete ...
A Long-Term Follow-Up Study Of Participants Treated With ...
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 ...
A2 Bio Announces First Patient Dosed in Phase 1/2 ...
A2 Bio to Present Early Safety and Efficacy Data from EVEREST-2 Study during 2025 Annual Meeting of the Society for Immunotherapy of Cancer.
results
*Received half dose level due to body weight. Case Report and Efficacy. • Patient 5 is a 60-year-old woman with a 45 pack-year smoking ...
6.
ctv.veeva.com
ctv.veeva.com/study/a-long-term-follow-up-study-of-participants-treated-with-a2-biotherapeutics-a2-bio-gene-therapy-gA Long-Term Follow-Up Study of Participants Treated With A2 ...
This is a long-term follow-up study designed to evaluate delayed safety events and long-term efficacy of A2 Bio GT products.
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