Glofitamab in Chinese Patients With R/R DLBCL

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: DLBCL - Diffuse Large B Cell Lymphoma

Treatments: Drug: Glofitamab

Study type: Observational

Funder types: Other

Identifiers

NCT06481826

Glofitamab-1

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

treatment group

Description:

Glofitamab

Treatment:

Drug: Glofitamab