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NOT YET RECRUITING
NCT07871747
PHASE1

Microbiome Intervention for CAR-T Optimization and Response (MICRO-CART)

Sponsor: University of Chicago

View on ClinicalTrials.gov

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

Interventions

DRUG

Live Biotherapeutic Product (LBP)

A Current Good Manufacturing Practice (cGMP) compliant oral bacterial consortium.

DRUG

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