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Microbiome Intervention for CAR-T Optimization and Response (MICRO-CART)
Sponsor: University of Chicago
Summary
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.
Official title: Merging Strategy That Uses Gut Microbiome Profiling and Targeted Modulation to Improve CAR-T Cell Therapy Outcomes, Predict Responses, and Reduce Toxicity
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2027-02-23
Completion Date
2030-09-10
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Live Biotherapeutic Product (LBP)
A Current Good Manufacturing Practice (cGMP) compliant oral bacterial consortium.
Placebo
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).
Locations (1)
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States