Gut Microbiome in DLBCL Treated With Glofitamab | NCT07498920

Studies
Gut Microbiome in DLBCL Treated With Glofitamab

NCT07498920

Sponsor

Peking Union Medical College Hospital

Status

Not yet recruiting

Last Update Posted

Mar 27, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

DLBCL
Glofitamab
Gut Biome

Interventions

Gut microbiome analysis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Apr 1, 2029Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Mar 23, 2026

First Submission Date that Met QC Criteria

Mar 23, 2026

First Posted Date

Mar 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2026

Last Update Posted Date

Mar 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GM group			Other: Gut microbiome analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gut microbiome analysis	Other	Gut microbiome analysis would be performed before and after glofitamab treatment in DLBCL patients.	GM group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

DLBCL patients planned to treated with glofitamab

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Jing Ruan	Contact	+8615201435860		15201435860@163.com

IPD Sharing Statement Module

Plan to Share IPD

Yes

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided