NCT07498920

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
42mo left

Started Apr 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Dec 2029

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

DLBCLGlofitamabGut Biome

Outcome Measures

Primary Outcomes (1)

  • Changes in gut microbiome

    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 Outcomes (1)

  • Correlation between gut microbiome and therapy outcomes in terms of response and toxicity

    2 years

Study Arms (1)

GM group

Other: Gut microbiome analysis

Interventions

Gut microbiome analysisOTHER

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

GM group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

DLBCL patients planned to treated with glofitamab

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Jing Ruan

CONTACT

+861520143586015201435860@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF