This study will evaluate the pharmacokinetics, safety, tolerability, and efficacy of glofitamab as a single agent following a fixed single dose of obinutuzumab 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will receive 1000 mg of intravenous (IV) obinutuzumab on Cycle 1 Day 1.
Participants will receive 2.5 mg of IV glofitamab Cycle 1 Day 8, 10 mg at Cycle 1 Day 15, and 30 mg on Day 1 of Cycles 2-12 Q3W (cycle length = 21 days).
Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).
Beijing Cancer Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
Guangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to 3.5 years
Serum Concentration of Glofitamab
Time frame: At pre-defined intervals up to 3.5 years
Total Exposure (AUC) of Glofitamab
Time frame: At pre-defined intervals up to 3.5 years
Maximum Serum Concentration (Cmax) of Glofitamab
Time frame: At pre-defined intervals up to 3.5 years
Minimum Serum Concentration (Cmin) of Glofitamab
Time frame: At pre-defined intervals up to 3.5 years
Clearance of Glofitamab
Time frame: At pre-defined intervals up to 3.5 years
Volume of Distribution at Steady State (Vss) of Glofitamab
Time frame: At pre-defined intervals up to 3.5 years
Half-life (T1/2) of Glofitamab
Time frame: At pre-defined intervals up to 3.5 years
Complete Response Rate (CRR) as Assessed by an Independent Review Committee (IRC)
Time frame: Up to 3.5 years
Percentage of Participants with Anti-Drug Antibodies (ADA)
Time frame: Up to 3.5 years
Investigator-Assessed CRR
Time frame: Up to 3.5 years
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Jiangsu Province Hospital
Nanjing, China
Tianjin Cancer Hospital
Tianjin, China
Objective Response Rate (ORR) as Assessed by IRC
Time frame: Up to 3.5 years
ORR as Assessed by Investigator
Time frame: Up to 3.5 years
Duration of Objective Response (DOR) as Assessed by IRC and Investigator
Time frame: Up to 3.5 years
Duration of Complete Response (CR) as Assessed by IRC and Investigator
Time frame: Up to 3.5 years
Progression-Free Survival (PFS) as Determined by IRC and Investigator
Time frame: Up to 3.5 years
Overall Survival (OS)
Time frame: Up to 3.5 years
Time to First Overall Response (TFOR) as Assessed by IRC and Investigator
Time frame: Up to 3.5 years
Time to First Complete Response (TFCR) as Assessed by IRC and Investigator
Time frame: Up to 3.5 years