University of Chicago
Chimeric Antigen Receptor T-Cell (CAR-T) therapy has transformed the management of large B-cell lymphoma, and multiple myeloma by achieving remarkable responses, yet inconsistent durability and severe toxicities remain major challenges. To bridge this gap, this Phase 1 trial evaluates the safety and tolerability of a cGMP-compliant oral Live Biotherapeutic Product (LBP) consortium, selected for its capacity to produce butyrate, as an adjunct to standard Chimeric Antigen Receptor T-Cell CAR-T therapy, aiming to restore microbiome function, and potentially improve clinical outcomes.
Inclusion Criteria: * Patients with a histologically confirmed Large B-Cell Lymphoma (LBCL) or Multiple Myeloma (MM) who are to receive a commercial Chimeric Antigen Receptor T-Cell (CAR-T) product per individual investigator. * Age ≥18 years. * ECOG performance status ≤2 (Karnofsky ≥60%). * Patient meets the eligibility criteria for the commercial CAR-T product they will receive (axi-cel, liso-cel, or cilta-cel), including the organ function, hematologic, and cardiopulmonary thresholds specified by institutional standard-of-care eligibility for CAR-T administration. * Ability to understand a…
A Current Good Manufacturing Practice (cGMP) compliant oral bacterial consortium.
A drug product manufactured to match the active Drug Product in appearance, composition, and packaging, but it does not contain the active ingredient (i.e., live bacterial organism).
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