Clinical trial · Observational
Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gut microbiome analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Characterization of GM heterogeneity (taxa) in diffuse large B-cell lymphoma patients undergoing CAR-T cell therapy.
- timeFrame
- 24 months
- description
- 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 (1)
- measure
- Correlation between GM and CAR-T cell therapy outcomes in terms of response, toxicity and disease control.
- timeFrame
- 4 years
- description
- Define novel GM signatures that relate to more favorable response to the CAR-T treatment and/or reducing the occurrence of side effects.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years. 2. Patients affected by histologically confirmed DLBCL. 3. Patients amenable for CAR-T cell therapy as for clinical approved indication (commercial products). 4. Patients must provide written informed consent. Exclusion Criteria: 1. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results. 2. Concurrent second malignancy.
References
Publications (0)
Data not yet available