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.

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Key information

Conditions

Diffuse Large B Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute Of Hematology "Seràgnoli"

Bologna, 40138, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥18 years.
Patients affected by histologically confirmed DLBCL.
Patients amenable for CAR-T cell therapy as for clinical approved indication (commercial products).
Patients must provide written informed consent.

Exclusion criteria

Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
Concurrent second malignancy.

Treatment and study plan

Gut microbiome analysis

Other

Characterization of the compositional and functional modifications of gut microbiome in patients affected by lymphoma undergoing therapy with CAR-T cells from baseline until the restaging after 18 months from the CAR-T cell infusion

Primary outcomes

Characterization of GM heterogeneity (taxa) in diffuse large B-cell lymphoma patients undergoing CAR-T cell therapy.

Time frame: 24 months

Characterization of the compositional and functional modifications of GM in patients affected by lymphoma undergoing therapy with CAR-T cells from baseline until the restaging after 18 months from the CAR-T cell infusion. GM profiling will be achieved by next-generation sequencing approaches, including 16S rRNA gene-based sequencing for diversity and compositional structure, and shotgun metagenomics for species-level and functional insights, including information on eukaryotes and viruses.

Secondary outcomes

Correlation between GM and CAR-T cell therapy outcomes in terms of response, toxicity and disease control.

Time frame: 4 years

Define novel GM signatures that relate to more favorable response to the CAR-T treatment and/or reducing the occurrence of side effects.

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Collaborators

Associazione Italiana per la Ricerca sul Cancro
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Registry information

Acronym: MicroCar

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Feb 13, 2023
Registry last updated: Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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