The purpose of this study is to evaluate the efficacy and safety of SCTB35 in Combination With Gemcitabine and Oxaliplatin vs Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
Age 18-80 years old
Histologically confirmed diffuse large B-cell lymphoma according to WHO 2022 criteria
Relapsed or refractory (R/R) disease following at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy
Participants who have failed after one prior line of therapy are not candidates for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
Prior treatment with antibodies targeting both CD20 and CD3
Contraindication to rituximab, gemcitabine or oxaliplatin, or prior treatment with an anti-CD20 antibody in combination with the GemOx regimen
Peripheral neuropathy assessed to be Grade >1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0 at enrollment
Known central nervous system (CNS) involvement by lymphoma
Parallel
SCTB35 injection
DrugSCTB35 will be subcutaneously administered at a dose as specified
Rituxumab
DrugParticipants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.
Gemcitabine
DrugParticipants will receive IV gemcitabine administration for up to 8 cycles.
Oxaliplatin
DrugParticipants will receive IV oxaliplatin administration for up to 8 cycles.
Adverse Events
Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Progression free survival (PFS)
Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.
Overall Survival (OS)
Overall survival is defined as the duration from the date of randomization to the date of the participant's death.
Percentage of Participants Achieving Best Overall Response (BOR)
BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria
Percentage of Participants Achieving CR
Percentage of participants who achieve a CR determined per Lugano criteria.
Duration of Response (DOR)
DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
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