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

ConditionsLymphoma, B-CellMultiple Myeloma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients who are receiving any other investigational agents.

Inability to swallow capsules.

Patients with known intestinal barrier dysfunction, including clinically active IBD (Crohn's or ulcerative colitis), GI bleed, enteropathy (including celiac disease), ischemic colitis, microscopic colitis, graft versus host disease, or malignant involvement of GI tract.

History of behavioral disorders, including substance abuse disorders, which, in the discretion of the primary investigator, will interfere with safe conduct and compliance with study treatment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Live Biotherapeutic Product (LBP)

    Drug

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

  • Placebo

    Drug

    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).

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Live Biotherapeutic Product (LBP) + Chimeric Antigen Receptor T-Cell (CAR-T) n=16Active comparator 1 intervention
Group B: Chimeric Antigen Receptor T-Cell (CAR-T) + placebo, n=16Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Assess safety and tolerability

Incidence and severity of adverse events Common Terminology Criteria for Adverse Events (CTCAE v5.0) and American Society for Transplantation and Cellular Therapy (ASTCT 2019).

Time frame
24 months from 1st dose of LBP/Placebo

Secondary outcomes

1

Assess engraftment of Live Biotherapeutic Product (LBP)

The proportion of LBP-treated patients will be reported with detectable engraftment of at least one consortium strain at each post-dosing timepoint, with exact 95% Clopper-Pearson confidence intervals.

Time frame
12 months after the last patient completes the 30-day dosing window
2

Assess engraftment of Fecal diversity

Analyses will include the number of consortium strains detected per patient at each timepoint will confirm that detected strains in the LBP arm reflect administered organisms rather than endogenous colonization

Time frame
12 months after the last patient completes the 30-day dosing window

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: