Glofitamab in Chinese Patients With R/R DLBCL

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

A Study to Evaluate Glofitamab as Single Agent in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

This study will evaluate the safety and efficacy of glofitamab as a single agent in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

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

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Description

Inclusion Criteria:

  1. Histologically-confirmed DLBCL
  2. Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy
  3. Participants must have measurable disease

Exclusion Criteria:

  1. Pregnancy or breastfeeding
  2. Patient with known active infection, or reactivation of a latent infection
  3. Patient with active autoimmune disease or immune deficiency
  4. severe organ failure：LVEF<40%；DLCO<40%；eGFR<30ml/min；Bilirubin≥3ULN
  5. Patients who are dependent on the sponsor, the investigator or the trial site

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
treatment group
Glofitamab
Drug: Glofitamab
Glofitamab given in standard dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 1 year
Progression-free survival
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 2 year
overall survival
2 year
CR rate
Time Frame: 6 weeks, 18 weeks, 36 weeks
complete response
6 weeks, 18 weeks, 36 weeks
ORR
Time Frame: 6 weeks, 18 weeks, 36 weeks
overall response rate
6 weeks, 18 weeks, 36 weeks
DOR
Time Frame: 2 year
duration of response
2 year
AE
Time Frame: 2 year
Rate and type of adverse events (AEs) and serious adverse events (SAEs)
2 year

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 1, 2024

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Glofitamab-1

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 Time Frame

3 years after the closure of the study

IPD Sharing Access Criteria

upon email request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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