CAR T-Cell Preparation for Cancer
(BASECAMP-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how often certain solid tumors, such as colorectal or lung cancer, lose specific immune markers. It also seeks to collect patients' T cells for potential future use in CAR T-Cell therapy, a type of immunotherapy. As an observational study, it does not involve administering new treatments but instead gathers crucial data that may aid in disease management. Suitable participants have advanced or hard-to-remove solid tumors and face a high risk of cancer recurrence within two years. As an unphased trial, this study allows patients to contribute to significant research that could influence future cancer treatments.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot have received any cancer therapy or investigational therapy within 2 weeks of the planned apheresis (blood cell collection) or 3 half-lives of the medication, whichever is shorter.
What prior data suggests that this protocol is safe for participants?
Research has shown that CAR T-cell therapy presents some known safety concerns. One study found no severe side effects at certain dose levels. However, important risks remain. The FDA has highlighted the potential for serious risks, such as T cell cancers. Additionally, CAR T-cell therapy can cause significant side effects, including cytokine release syndrome (CRS), a severe immune reaction, and neurotoxicity, which can affect the brain.
These findings suggest that while CAR T-cell therapy holds promise, considering these safety issues is important. Prospective trial participants should discuss these risks with their healthcare provider.12345Why are researchers excited about this trial?
Unlike traditional treatments for solid tumors, such as surgery, chemotherapy, or radiation, CAR T-cell therapy is unique because it harnesses the power of the immune system to fight cancer. Researchers are excited about CAR T-cell therapy because it involves engineering a patient's own T-cells to better recognize and attack cancer cells. This personalized approach not only offers the potential for more precise targeting of tumors, but it may also reduce the collateral damage typically associated with standard treatments. By focusing on the loss of heterozygosity (LOH), an important genetic marker in tumors, this trial aims to enhance the effectiveness and specificity of CAR T-cell therapy, potentially leading to improved outcomes for patients.
What evidence suggests that CAR T-Cell Therapy might be an effective treatment for solid tumor cancer?
Research has shown that CAR T-cell therapy holds promise for treating various types of cancer. Specifically, studies have found that 55% to 68% of patients with certain blood cancers had no detectable cancer after treatment. Additionally, about 60% of these patients remained cancer-free for at least five years. This therapy modifies a patient's own T-cells (a type of immune cell) to enhance their ability to fight cancer cells. While side effects like nerve problems can occur, many patients experience better results and an improved quality of life. These findings suggest CAR T-cell therapy could also benefit solid tumors, although most current data comes from blood cancer studies.678910
Who Is on the Research Team?
Eric W Ng, MD, FAAP
Principal Investigator
A2 Biotherapeutics Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening (Part 1 and 2)
Participants are screened for eligibility to participate in the trial
Enrollment (Apheresis)
Participants undergo apheresis for Peripheral Blood Mononuclear Cell (PBMC) collection to store their T cells
Post Apheresis Safety Follow-up
Participants are monitored for adverse events related to apheresis
Two-year Long Term Follow-up
Participants are followed for up to 2 years to monitor their status for potential enrollment in a future interventional study
What Are the Treatments Tested in This Trial?
Interventions
- CAR T-Cell Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
A2 Biotherapeutics Inc.
Lead Sponsor
Tempus AI
Industry Sponsor
Tempus Labs
Industry Sponsor