A2B530 CAR T Therapy for Solid Cancers
(EVEREST-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called A2B530, a type of CAR T-cell therapy, for individuals with certain solid cancers such as colorectal, pancreatic, and lung cancer. The first phase aims to determine the safest dose, while the second phase evaluates its effectiveness in targeting cancer cells without harming healthy ones. It suits those whose tumors express a specific protein (CEA) and who have not succeeded with other treatments. Participants should have tumors that cannot be surgically removed or treated with standard therapies. They must be willing to adhere to the study's schedule, including safety follow-ups. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have had cancer therapy within 3 weeks or 3 half-lives of the A2B530 infusion. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that A2B530 CAR T therapy is likely to be safe for humans?
Research has shown that A2B530, a new CAR T-cell therapy, could be promising for treating solid tumors, with a focus on safety. Early studies found that this treatment aims to avoid common problems with CAR T therapies, such as mistakenly attacking healthy cells, known as on-target, off-tumor toxicity.
In these studies, researchers tested A2B530 on patients with solid tumors, including colorectal, pancreatic, and lung cancers. The treatment was generally well-tolerated. Some patients experienced side effects, but these are common with many new treatments and are closely monitored by the researchers.
Overall, these early findings suggest that A2B530 is safe for humans, with the goal of finding the best dose that balances effectiveness and safety. However, ongoing studies are essential to fully understand its safety.12345Why are researchers excited about this possible treatment for solid cancers?
Researchers are excited about A2B530 CAR T Therapy because it represents a new way to tackle solid cancers. Unlike traditional treatments like chemotherapy or radiation, A2B530 uses engineered T-cells, which are part of the immune system, to specifically target and attack cancer cells. This method not only aims to enhance precision in targeting tumors but also minimizes damage to healthy cells. The single-dose administration post-preconditioning lymphodepletion suggests a potentially quicker and more focused therapeutic action, which is a promising advancement over existing options.
What evidence suggests that A2B530 might be an effective treatment for solid tumors?
Research has shown that A2B530, a type of CAR T-cell therapy, might effectively target solid tumors such as colorectal, pancreatic, and non-small cell lung cancers. This treatment enables T-cells, part of the immune system, to specifically attack cancer cells while sparing healthy ones. A2B530 also addresses common issues in similar treatments, such as harming healthy tissues. Early studies suggest that patients tolerate the treatment well, with no serious side effects reported. This promising method uses the immune system to fight cancer more safely and effectively.12356
Who Is on the Research Team?
Eric Ng, MD
Principal Investigator
A2 Biotherapeutics Inc.
Are You a Good Fit for This Trial?
This trial is for adults with certain solid tumors like colorectal, pancreatic, or non-small cell lung cancer that express CEA and lack HLA-A*02. They must have a life expectancy of at least 3 months, be able to follow the study plan including long-term safety checks, and have completed necessary prior treatments. Pregnant or breastfeeding individuals are excluded as well as those not using birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preconditioning Lymphodepletion (PCLD) Regimen
Participants receive a preconditioning lymphodepletion regimen before the infusion of A2B530 Tmod CAR T cells
Treatment
Participants receive a single dose of A2B530 intravenously on day 0
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and dose limiting toxicities
What Are the Treatments Tested in This Trial?
Interventions
- A2B530
A2B530 is already approved in United States for the following indications:
- Colorectal cancer with germline heterozygous HLA-A*02-positive disease expressing carcinoembryonic antigen and lost HLA-A*02 expression
Find a Clinic Near You
Who Is Running the Clinical Trial?
A2 Biotherapeutics Inc.
Lead Sponsor
Tempus AI
Industry Sponsor
Tempus Labs
Industry Sponsor