CAR-T Therapy + Pneumococcal Vaccination for Blood Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how a vaccine and clinic visits benefit people with blood cancers undergoing CAR-T therapy, a treatment that uses modified cells to fight cancer. The study aims to determine if the vaccine can protect against infections and if clinic visits can effectively track health changes. Individuals planning to receive CAR-T therapy for blood cancers, who are willing to attend regular clinic visits and provide blood samples, are well-suited for this trial. As a Phase 1/Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CAR-T cell therapy, both experimental and approved, has been very successful in treating blood cancers. However, this therapy can cause serious side effects. Common issues include cytokine release syndrome (CRS), which can cause severe flu-like symptoms, and other problems that might require a long recovery time.
For approved CAR-T therapies, about 4.3% of patients have developed a second type of cancer after treatment. Despite these risks, many patients experience significant improvements, marking this therapy as a major advancement in treating certain blood cancers.
While experimental CAR-T treatments are still under investigation, they present similar safety concerns as the approved ones. These studies are crucial to ensure the treatment's safety and efficacy.
In summary, while CAR-T therapy can have serious side effects, it remains a powerful treatment for blood cancers. Participants should discuss the potential risks and benefits with their healthcare providers.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these CAR-T treatments for blood cancers because they use genetically modified T cells to target and destroy cancer cells effectively. Unlike traditional chemotherapy and radiation, which can harm healthy cells and cause significant side effects, CAR-T therapies are designed to precisely target cancer cells, potentially offering a more personalized and less toxic treatment option. The investigational CAR-T therapy being studied may provide enhanced targeting capabilities or improved effectiveness compared to commercial CAR-T products. By combining CAR-T therapy with pneumococcal vaccination, there is also the potential to boost patients' immune responses, helping to prevent infections that can occur during cancer treatment.
What evidence suggests that this trial's treatments could be effective for blood cancers?
Research has shown that CAR-T cell therapy effectively treats blood cancers. In this trial, participants will receive either investigational CAR-T therapy or commercial CAR-T therapy. Studies indicate that patients using experimental CAR-T therapy have about an 82% chance of remission, with many experiencing complete remission. For approved CAR-T therapy, the results are also promising. Specifically, one study found that 86% of patients responded positively, and 52% went into complete remission. These findings suggest that both investigational and commercial CAR-T therapies could be powerful options for managing blood cancers.12467
Who Is on the Research Team?
Natalie Grover, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with various blood cancers who are undergoing CAR-T cell therapy. It's open to those receiving either commercial or investigational CAR-T treatments, and participants will be monitored for immune system recovery and response to pneumococcal vaccination.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepletion and CAR-T Cell Infusion
Participants undergo lymphodepletion followed by CAR-T cell infusion
Immune Reconstitution Monitoring
Participants attend Immune Reconstitution Clinic Visits at 3, 6, 9, and 12 months post-CAR-T infusion for blood sample collection and assessment
Vaccination
Pneumococcal vaccination (PCV-21) offered at 6 months post-CAR-T infusion, with additional blood samples collected at 9 and 12 months to assess vaccine efficacy
Long-term Follow-up
Participants are monitored for up to 24 months post-CAR-T infusion via medical chart abstraction
What Are the Treatments Tested in This Trial?
Interventions
- Commercial CAR-T
- Investigational CAR-T
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor