Gut Microbiome in DLBCL Treated With Glofitamab

March 23, 2026 updated by: Ruanjing, Peking Union Medical College Hospital

Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With Glofitamab

The gut microbiome (GM) has recently emerged as one of the key modifiable factors of response and prognosis to immunotherapy in cancer patients. Currently, it is unknown if GM also modulates anti-tumor responses to T cell engagers (TCE) including glofitamab in DLBCL patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observation study to evaluate the role of gut microbiome in DLBCL patients treated by glofitamab.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

DLBCL patients planned to treated with glofitamab

Description

Inclusion Criteria:

  1. Histologically/cytologically confirmed diagnosis of DLBCL
  2. Is being planned to received Glofitamab
  3. Be able to 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GM group
Other: Gut microbiome analysis
Gut microbiome analysis would be performed before and after glofitamab treatment in DLBCL patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in gut microbiome
Time Frame: 2 years
Characterization of the compositional and functional modifications of gut microbiome in DLBCL patients treated with glofitamab from baseline to 1 year after the end of treatment.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between gut microbiome and therapy outcomes in terms of response and toxicity
Time Frame: 2 years
Correlation between gut microbiome and therapy outcomes in terms of response and toxicity
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Glofitamab-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the study protocol, statistical analysis plan, informed consent form, clinical study report would be available upon email request in 3 years after the closure of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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