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Could the key to better CAR-T therapy lie in the gut?

NCT ID NCT05725720

Knowledge-focused Sponsor: University of Bologna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B cell lymphoma

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.