NCT07570823RecruitingPhase 3
A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Sinocelltech Ltd.
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Adverse Events
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
R-GemOx
Active Comparator
Intervention: Oxaliplatin (Drug)
SCTB35-GemOx
Experimental
Intervention: SCTB35 injection (Drug)
R-GemOx
Active Comparator
Intervention: Rituxumab (Drug)
SCTB35-GemOx
Experimental
Intervention: Gemcitabine (Drug)
R-GemOx
Active Comparator
Intervention: Gemcitabine (Drug)
SCTB35-GemOx
Experimental
Intervention: Oxaliplatin (Drug)
Outcomes
Primary Outcomes
Adverse Events
Time Frame: Up to approximately 3 years
Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Progression free survival (PFS)
Time Frame: 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.
Secondary Outcomes
- Overall Survival (OS)(Up to approximately 3 years)
- Percentage of Participants Achieving Best Overall Response (BOR)(Up to approximately 3 years)
- Percentage of Participants Achieving CR(Up to approximately 3 years)
- Duration of Response (DOR)(Up to approximately 3 years)
- Duration of Complete Response (DOCR)(Up to approximately 3 years)
- Time to Response (TTR)(Up to approximately 3 years)
- Time to Complete Response (TTCR)(Up to approximately 3 years)
- Event-Free Survival (EFS)(Up to approximately 3 years)
- Blood Concentrations of SCTB35(Up to approximately 1 years)
- Anti-drug Antibodies of SCTB35(Up to approximately 3 years)
Investigators
Study Sites (1)
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