Diffuse Large B-Cell Lymphoma
Conditions
Brief summary
This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (JS203-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.
Detailed description
A Randomized Open-Label Multicenter Phase III Clinical Trial Comparing JS203 Combined With gemcitabine plus oxaliplatin (JS203-GemOx) Versus rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Interventions
COMBINATION_PRODUCTJS203 in combination with gemcitabine and oxaliplatin
gemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days/cycle) Cycle 1 QW,Cycle 2 and therafter Q3W for up to 1 year
COMBINATION_PRODUCTRituximab in combination with gemcitabine and oxaliplatin
Rituximab and gemcitabine and oxaliplatin 8 cycles (Q3W)
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients must meet all of the following inclusion criteria to be enrolled: * Age range: 18 to 75 years old (inclusive), both male and female are acceptable * ECOG: 0-1； * One of the confirmed histologies below with CD20-positivity: DLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL)/Marginal Zone Lymphoma(MZL) "Double-hit" or "triple-hit" DLBCL , including de novo or histologically transformed from FL/MZL FL Grade 3B T-cell/histiocyte-rich large B-cell lymphoma * At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment； * Acceptable organ function at screening；
Exclusion criteria
* A history of severe allergy to monoclonal antibody therapy (or recombinant antibody-related fusion protein)； * Previously received CD20-CD3 bispecific antibody treatment； * Previous allogeneic hematopoietic stem cell transplantation； * Previous solid organ transplantation * History of autoimmune diseases * Patients with a history of macrophage activation syndrome (MAS)/ hemophagocytic lymphohistiocytosis (HLH) * Patients with a history of progressive multifocal leukoencephalopathy (PML) * A known or suspected history of CNS lymphoma (including primary or secondary) * There is pleural effusion, peritoneal effusion or pericardial effusion that requires treatment (such as puncture or drainage)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | up to approximately 24 months | Overall survival (OS) evaluated based on 2014 Lugano criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of complete response (DoCR) | up to approximately 12 months | Duration of complete response (DoCR) evaluated based on 2014 Lugano criteria |
| Adverse events (AE) | up to approximately 15 months | Incidence and severity of all adverse events (AE) that occurred during the clinical trial |
| PK | up to approximately 15 months | The serum drug concentration of JS203 |
| ADA | up to approximately 15 months | The incidence and titer of the anti-drug antibody (ADA) of JS203 |
| NAb | up to approximately 15 months | The incidence of neutralizing antibodies (NAb) of JS203 (if applicable) |
| Objective response rate (ORR) | up to approximately 12 months | Objective response rate (ORR) based on 2014 Lugano criteria |
| Duration of response (DoR) | up to approximately 12 months | Duration of response (DoR) evaluated based on 2014 Lugano criteria |
| complete response (CR) | up to approximately 12 months | The complete response rate (CR) evaluated based on 2014 Lugano criteria |
Countries
China
Contacts
CONTACTNiannian Wang
Outcome results
None listed