MicroCar: Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Characterization of GM heterogeneity (taxa) in diffuse large B-cell lymphoma patients undergoing CAR-T cell therapy. [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 Outcome Measures
- Correlation between GM and CAR-T cell therapy outcomes in terms of response, toxicity and disease control. [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years.
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Patients affected by histologically confirmed DLBCL.
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Patients amenable for CAR-T cell therapy as for clinical approved indication (commercial products).
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Patients must provide written informed consent.
Exclusion Criteria:
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Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
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Concurrent second malignancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute Of Hematology "Seràgnoli" | Bologna | Italy | 40138 |
Sponsors and Collaborators
- University of Bologna
- Associazione Italiana per la Ricerca sul Cancro
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IG2022id27350