DLBCLNCT07498920
Gut Microbiome in DLBCL Treated With Glofitamab
An observational study of DLBCL and Glofitamab, run by Peking Union Medical College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- DLBCL, Glofitamab, Gut Biome
- What is being tested?
- Gut microbiome analysis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: DLBCL patients planned to treated with glofitamab
Who may be able to join
- Histologically/cytologically confirmed diagnosis of DLBCL
- Is being planned to received Glofitamab
- Be able to provide written informed consent
Who cannot join
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
- Concurrent second malignancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
This is a prospective observation study to evaluate the role of gut microbiome in DLBCL patients treated by glofitamab.
- Conditions
- DLBCL, Glofitamab, Gut Biome
- Being tested
- Gut microbiome analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut microbiome analysisOther
Gut microbiome analysis would be performed before and after glofitamab treatment in DLBCL patients.
| Study group | Role | What they receive |
|---|---|---|
| GM group | Not described Receives: Other: Gut microbiome analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCLStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruanjing, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498920
- Sponsor's protocol ID
- Glofitamab-2
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With Glofitamab
- ClinicalTrials.gov ID
- NCT07498920
- Acronym / sponsor ID
- Glofitamab-2
- Conditions
- DLBCL, Glofitamab, Gut Biome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GM group | – | Other: Gut microbiome analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- DLBCL patients planned to treated with glofitamab
Key inclusion criteria (3 listed)
- Histologically/cytologically confirmed diagnosis of DLBCL
- Is being planned to received Glofitamab
- Be able to provide written informed consent
Key exclusion criteria (2 listed)
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
- Concurrent second malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gut microbiome analysisGut microbiome analysis would be performed before and after glofitamab treatment in DLBCL patients. | Other | GM group |
Primary outcome
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.
1 secondary outcome
Correlation between gut microbiome and therapy outcomes in terms of response and toxicity
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of DLBCL and Glofitamab, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Ruan (+8615201435860, 15201435860@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiome (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.