About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- SCTB35 injection
- Rituxumab
- Gemcitabine
- Oxaliplatin