Clinical trial

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

Name
Glofitamab-1
Description
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.
Trial arms
Trial start
2024-01-01
Estimated PCD
2027-12-31
Trial end
2028-12-31
Status
Recruiting
Treatment
Glofitamab
Glofitamab given in standard dosage
Arms:
treatment group
Size
20
Primary endpoint
PFS
1 year
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '3 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2024-07-01

1 organization

1 product

1 indication

Product
Glofitamab