Could the key to better CAR-T therapy lie in the gut?
NCT ID NCT05725720
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This study explores whether the types of bacteria living in a person's gut can influence how well CAR-T cell therapy works for diffuse large B-cell lymphoma. Researchers will track changes in the gut microbiome of 69 patients from before treatment up to 18 months afterward. The goal is to see if certain bacterial patterns are linked to better responses or fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gut microbiome analysis (no drug or treatment given)
- What this could lead to
- If certain gut bacteria are linked to better CAR-T responses, this could point toward ways to improve treatment outcomes by modifying the microbiome.
- What could go wrong
- This is an observational study, not a treatment trial. It may find no clear link between gut bacteria and CAR-T outcomes, or the findings may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
69 people
The number who actually took part.
- Started
-
Mar 2023
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Up to 90 relapsed/refractory diffuse large B-cell lymphoma adult (≥18 years) patients undergoing CAR-T cell therapy will be enrolled over 3 years, treated and followed up with fecal sample collection until 18 months after CAR-T cell infusion.
- Ages
-
18 years and older
- Sex
-
Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Institute Of Hematology "Seràgnoli"
Bologna, 40138, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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