Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy

Despite impressive outcomes in selected patients, significant heterogeneity in clinical response to CAR-T cell therapy remains. The gut microbiome (GM) has recently emerged as one of the key modifiable factors of prognosis and response to treatment in cancer patients, with high-diversity profiles rich in health-associated taxa while poor in pathobionts generally associated with better response and longer survival. Currently, it is unknown if GM also modulates anti-tumor responses to CAR-T cells and related toxicities in lymphomas.

NCT Number	NCT05725720
Lead Sponsor	University of Bologna Collaborators: Associazione Italiana per la Ricerca sul Cancro, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions	Diffuse Large B Cell Lymphoma
Enrollment	69 participants
Start Date	2023-03-23
Primary Completion	2027-07 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-24