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
SCTB35 injection: SCTB35 will be subcutaneously administered at a dose as specified
Rituxumab: Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.
Gemcitabine: Participants will receive IV gemcitabine administration for up to 8 cycles.
Oxaliplatin: Participants will receive IV oxaliplatin administration for up to 8 cycles.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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)
* Presence of measurable or evaluable disease at baseline ECOG PS 0-2
* ECOG PS 0-2
* Adequate organ function and bone marrow function
* Expected survival ≥ 3 months
Exclusion Criteria:
* 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
* Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks
* Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to first SCTB35 administration
* Autologous HSCT within 100 days prior to first SCTB35 administration, or any prior allogeneic HSCT or solid organ transplantation
* Major surgery within 4 weeks prior to first SCTB35 administration
* Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to first SCTB35 administration
* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
Primary outcome measure(s)
Adverse Events — Up to approximately 3 years Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Progression free survival (PFS) — Up to approximately 3 years 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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