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NCT Number: NCT07498920

Gut Microbiome in DLBCL 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.

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Key information

Conditions

DLBCL Glofitamab Gut Biome

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically/cytologically confirmed diagnosis of DLBCL
  • Is being planned to received Glofitamab
  • Be able to provide written informed consent

Exclusion criteria

  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
  • Concurrent second malignancy.

Treatment and study plan

Gut microbiome analysis

Other

Gut microbiome analysis would be performed before and after glofitamab treatment in DLBCL patients.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Ruan

CONTACT

[email protected]

+8615201435860

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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