A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSinocelltech Ltd.

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

Treatment groups

101 Participants
are divided into 2 treatment groups

Sponsors and collaborators