Live Biotherapeutic Product for B-Cell Lymphoma

((MICRO-CART) Trial)

This trial tests whether adding a special type of gut-friendly bacteria (Live Biotherapeutic Product) to existing CAR-T cell therapy can make treatment for large B-cell lymphoma and multiple myeloma safer and more effective. CAR-T therapy has shown great success in fighting these cancers, but it can cause severe side effects and may not provide lasting results. By improving gut health, researchers aim to enhance the treatment's benefits. Individuals with large B-cell lymphoma or multiple myeloma who are already scheduled to receive CAR-T therapy might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Research has shown that Live Biotherapeutic Products (LBPs) are generally safe for people. These treatments use live bacteria to help restore balance in the body. Although specific safety data can be limited, studies have demonstrated that LBPs have been used safely in various research. Manufacturers design them to be safe and effective, and they carefully check for any harmful contaminants during production.

Researchers are excited about using a Live Biotherapeutic Product (LBP) for B-cell lymphoma because it offers a new way to enhance the effectiveness of existing therapies. Unlike traditional treatments, which primarily focus on directly attacking cancer cells, this approach involves modulating the gut microbiota. This modulation is thought to improve the efficacy of Chimeric Antigen Receptor T-Cell (CAR-T) therapy, which is already a powerful tool against lymphoma. By potentially boosting the immune system's response, LBP may lead to better outcomes for patients.

Research has shown that treatments using live microorganisms, known as live biotherapeutic products (LBPs), hold promise in cancer care. Some patients have experienced long-term survival without tumors. In this trial, one group of participants will receive a combination of LBPs and Chimeric Antigen Receptor T-Cell (CAR-T) therapy, which may enhance gut health and support cancer therapies like CAR-T therapy. Another group will receive CAR-T therapy with a placebo, serving as a control for comparison. One study found that LBPs helped 30% of patients live tumor-free for over ten years. The gut microbiome, the community of microbes in the digestive system, might influence both the development and treatment of diffuse large B-cell lymphoma. By improving gut health, these treatments could enhance existing cancer therapies, potentially leading to better outcomes for patients.⁶⁷⁸⁹¹⁰